Contour ProtégéAI+

K250035

MIM Software Inc. · cleared 2025-02-03 · product code QKB · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.6)

“Contour ProtégéAl+ is an accessory to MIM software that automatically creates contours on medical images through the use of machine-learning algorithms. It is designed for use in the processing of medical images and operates on Windows, Mac, and Linux computer systems. Contour ProtégéAl+ is deployed on a remote server using the MIMcloud service for data management and transfer; or locally on the workstation or server running MIM software.”

Algorithmmachine-learning algorithms

source quote (p.6)

“Contour ProtégéAl+ is an accessory to MIM software that automatically creates contours on medical images through the use of machine-learning algorithms.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=770 images · 32 site(s)

endpoints: Statistical non-inferiority of the Dice score compared with the reference predicate; Statistical non-inferiority of the MDA score compared with the reference predicate; Average user evaluation of 2 or higher, when measured on a three-point scale; Statistically non-inferior cumulative APL compared to the reference predicate; Localization accuracy

Reported performance (76 observations)

diceas written: “Dice score (BrachialPlex_L)”0.41CI ± 0.15

source quote (p.13)

“0.41 ± 0.15”

diceas written: “Dice score (BrachialPlex_R)”0.39CI ± 0.15

source quote (p.13)

“0.39 ± 0.15”

diceas written: “Dice score (Breast_L)”0.79CI ± 0.07

source quote (p.13)

“0.79 ± 0.07”

diceas written: “Dice score (Breast_R)”0.8CI ± 0.11

source quote (p.13)

“0.80 ± 0.11”

diceas written: “Dice score (Breast_L_RTOG)”0.77CI ± 0.11

source quote (p.13)

“0.77 ± 0.11”

diceas written: “Dice score (Breast_R_RTOG)”0.77CI ± 0.15

source quote (p.13)

“0.77 ± 0.15”

diceas written: “Dice score (Bronchus)”0.62CI ± 0.14

source quote (p.13)

“0.62 ± 0.14”

diceas written: “Dice score (Carina)”0.5CI ± 0.12

source quote (p.13)

“0.50 ± 0.12”

diceas written: “Dice score (Cricoid)”0.06CI ± 0.05

source quote (p.13)

“0.06 ± 0.05”

diceas written: “Dice score (Esophagus)”0.69CI ± 0.16

source quote (p.13)

“0.69 ± 0.16”

diceas written: “Dice score (Glnd_Thyroid)”0.66CI ± 0.18

source quote (p.13)

“0.66 ± 0.18”

diceas written: “Dice score (GreatVes)”0.7CI ± 0.16

source quote (p.13)

“0.70 ± 0.16”

diceas written: “Dice score (Heart)”0.9CI ± 0.07

source quote (p.13)

“0.90 ± 0.07”

diceas written: “Dice score (Humerus_Head_L)”0.62CI ± 0.24

source quote (p.13)

“0.62 ± 0.24”

diceas written: “Dice score (Humerus_Head_R)”0.6CI ± 0.22

source quote (p.13)

“0.60 ± 0.22”

diceas written: “Dice score (Kidney_L)”0.9CI ± 0.09

source quote (p.14)

“0.90 ± 0.09”

diceas written: “Dice score (Kidney_R)”0.89CI ± 0.09

source quote (p.14)

“0.89 ± 0.09”

diceas written: “Dice score (Larynx)”0.59CI ± 0.14

source quote (p.14)

“0.59 ± 0.14”

diceas written: “Dice score (Liver)”0.9CI ± 0.13

source quote (p.14)

“0.90 ± 0.13”

diceas written: “Dice score (Lung_L)”0.96CI ± 0.02

source quote (p.14)

“0.96 ± 0.02”

diceas written: “Dice score (Lung_R)”0.97CI ± 0.03

source quote (p.14)

“0.97 ± 0.03”

diceas written: “Dice score (Musc_Constrict)”0.5CI ± 0.17

source quote (p.14)

“0.50 ± 0.17”

diceas written: “Dice score (Pancreas)”0.47CI ± 0.21

source quote (p.14)

“0.47 ± 0.21”

diceas written: “Dice score (SpinalCord)”0.64CI ± 0.17

source quote (p.14)

“0.64 ± 0.17”

diceas written: “Dice score (Stomach)”0.73CI ± 0.21

source quote (p.14)

“0.73 ± 0.21”

diceas written: “Dice score (Trachea)”0.74CI ± 0.17

source quote (p.14)

“0.74 ± 0.17”

diceas written: “Dice score (A_LAD)”0.32CI ± 0.12

source quote (p.14)

“0.32 ± 0.12”

diceas written: “Dice score (A_Aorta_Asc)”0.83CI ± 0.17

source quote (p.14)

“0.83 ± 0.17”

diceas written: “Dice score (Rib)”0.28CI ± 0.11

source quote (p.14)

“0.28 ± 0.11”

diceas written: “Dice score (Chestwall_L)”0.39CI ± 0.17

source quote (p.14)

“0.39 ± 0.17”

diceas written: “Dice score (Chestwall_R)”0.42CI ± 0.18

source quote (p.14)

“0.42 ± 0.18”

diceas written: “Dice score (LN_Ax_L1_L)”0.63CI ± 0.10

source quote (p.14)

“0.63 ± 0.10”

diceas written: “Dice score (LN_Ax_L1_R)”0.58CI ± 0.13

source quote (p.15)

“0.58 ± 0.13”

diceas written: “Dice score (LN_Ax_L2_L)”0.64CI ± 0.13

source quote (p.15)

“0.64 ± 0.13”

diceas written: “Dice score (LN_Ax_L2_R)”0.6CI ± 0.18

source quote (p.15)

“0.60 ± 0.18”

diceas written: “Dice score (LN_Ax_L3_L)”0.62CI ± 0.19

source quote (p.15)

“0.62 ± 0.19”

diceas written: “Dice score (LN_Ax_L3_R)”0.52CI ± 0.17

source quote (p.15)

“0.52 ± 0.17”

diceas written: “Dice score (LN_IMN_L)”0.41CI ± 0.17

source quote (p.15)

“0.41 ± 0.17”

diceas written: “Dice score (LN_IMN_R)”0.48CI ± 0.20

source quote (p.15)

“0.48 ± 0.20”

diceas written: “Dice score (LN_Sclav_L)”0.66CI ± 0.13

source quote (p.15)

“0.66 ± 0.13”

diceas written: “Dice score (LN_Sclav_R)”0.55CI ± 0.09

source quote (p.15)

“0.55 ± 0.09”

diceas written: “Dice score (Bladder)”0.92CI ± 0.16

source quote (p.15)

“0.92 ± 0.16”

diceas written: “Dice score (Bowel)”0.52CI ± 0.19

source quote (p.15)

“0.52 ± 0.19”

diceas written: “Dice score (BowelBag)”0.36CI ± 0.11

source quote (p.15)

“0.36 ± 0.11”

diceas written: “Dice score (CaudaEquina)”0.69CI ± 0.13

source quote (p.15)

“0.69 ± 0.13”

diceas written: “Dice score (Kidney_L)”0.94CI ± 0.03

source quote (p.15)

“0.94 ± 0.03”

diceas written: “Dice score (Kidney_R)”0.92CI ± 0.07

source quote (p.15)

“0.92 ± 0.07”

diceas written: “Dice score (Liver)”0.93CI ± 0.08

source quote (p.15)

“0.93 ± 0.08”

diceas written: “Dice score (SpinalCord)”0.65CI ± 0.14

source quote (p.15)

“0.65 ± 0.14”

diceas written: “Dice score (Stomach)”0.82CI ± 0.11

source quote (p.16)

“0.82 ± 0.11”

diceas written: “Dice score (Bladder - Female Pelvis)”0.91CI ± 0.06

source quote (p.16)

“0.91 ± 0.06”

diceas written: “Dice score (Bag_Bowel)”0.52CI ± 0.20

source quote (p.16)

“0.52 ± 0.20”

diceas written: “Dice score (Bowel - Female Pelvis)”0.55CI ± 0.19

source quote (p.16)

“0.55 ± 0.19”

diceas written: “Dice score (Colon_Sigmoid)”0.47CI ± 0.24

source quote (p.16)

“0.47 ± 0.24”

diceas written: “Dice score (Femur_Head_L)”0.91CI ± 0.08

source quote (p.16)

“0.91 ± 0.08”

diceas written: “Dice score (Femur_Head_R)”0.92CI ± 0.02

source quote (p.16)

“0.92 ± 0.02”

diceas written: “Dice score (UteroCervix)”0.65CI ± 0.27

source quote (p.16)

“0.65 ± 0.27”

diceas written: “Dice score (LN_Pelvics)”0.74CI ± 0.06

source quote (p.16)

“0.74 ± 0.06”

diceas written: “Dice score (Rectum)”0.75CI ± 0.12

source quote (p.16)

“0.75 ± 0.12”

diceas written: “Dice score (SacralPlex)”0.03CI ± 0.01

source quote (p.16)

“0.03 ± 0.01”

diceas written: “Dice score (Sacrum)”0.89CI ± 0.01

source quote (p.16)

“0.89 ± 0.01”

diceas written: “Dice score (CaudaEquina - SurePlan MRT)”0.66CI ± 0.11

source quote (p.16)

“0.66 ± 0.11”

diceas written: “Dice score (Bone)”0.83CI ± 0.05

source quote (p.16)

“0.83 ± 0.05”

diceas written: “Dice score (Glnd_Lacrimal_L)”0.3CI ± 0.21

source quote (p.16)

“0.30 ± 0.21”

diceas written: “Dice score (Glnd_Lacrimal_R)”0.36CI ± 0.23

source quote (p.16)

“0.36 ± 0.23”

diceas written: “Dice score (Glnd_Subman_L)”0.67CI ± 0.29

source quote (p.16)

“0.67 ± 0.29”

diceas written: “Dice score (Glnd_Subman_R)”0.66CI ± 0.16

source quote (p.17)

“0.66 ± 0.16”

diceas written: “Dice score (Glnd_Thyroid)”0.75CI ± 0.12

source quote (p.17)

“0.75 ± 0.12”

diceas written: “Dice score (Kidney_L - SurePlan MRT)”0.91CI ± 0.04

source quote (p.17)

“0.91 ± 0.04”

diceas written: “Dice score (Kidney_R - SurePlan MRT)”0.91CI ± 0.03

source quote (p.17)

“0.91 ± 0.03”

diceas written: “Dice score (Liver - SurePlan MRT)”0.93CI ± 0.07

source quote (p.17)

“0.93 ± 0.07”

diceas written: “Dice score (Lung_L - SurePlan MRT)”0.96CI ± 0.04

source quote (p.17)

“0.96 ± 0.04”

diceas written: “Dice score (Lung_R - SurePlan MRT)”0.96CI ± 0.05

source quote (p.17)

“0.96 ± 0.05”

diceas written: “Dice score (Parotid_L)”0.81CI ± 0.05

source quote (p.17)

“0.81 ± 0.05”

diceas written: “Dice score (Parotid_R)”0.82CI ± 0.05

source quote (p.17)

“0.82 ± 0.05”

diceas written: “Dice score (Spleen)”0.95CI ± 0.02

source quote (p.17)

“0.95 ± 0.02”

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

re_clearance
The FDA AI/ML device list shows a newer 510(k) K253270 (decision 2026-03-27) from Mim Software, Inc. for a matching device line ("Contour ProtégéAI+") — a new clearance for the same line is a change event. The newer clearance's parsed summary mentions a PCCP.
first seen 2026-07-08 · k_number:K253270

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Final guidanceRadiology-specific2022-09
Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data - Premarket Notification [510(k)] Submissions
Radiology CADe/CADx · Software premarket content
Original July 2012; current database date reflects a Sept 2022 reissue. Governs CADe device 510(k) content.
Final guidanceRadiology-specific2022-09
Clinical Performance Assessment: Considerations for Computer-Assisted Detection Devices Applied to Radiology Images and Radiology Device Data in Premarket Notification (510(k)) Submissions
Radiology CADe/CADx
Original July 2012, revised 2020; current database date Sept 2022. Covers standalone and reader-study performance assessment for CADe.
Final guidanceRadiology-specific2022-06
Technical Performance Assessment of Quantitative Imaging in Radiological Device Premarket Submissions
Quantitative imaging · Radiology CADe/CADx
Final (June 2022). Relevant to devices outputting quantitative imaging measurements.
Final guidance2026-01
Clinical Decision Support Software
Clinical decision support · SaMD (general)
New final guidance issued Jan 2026, superseding the Sept 2022 version; narrows the device-CDS scope. Applies to software that informs clinical management.
Final guidance2026-01
General Wellness: Policy for Low Risk Devices
SaMD (general) · Clinical decision support
Revised final (Jan 2026); now addresses noninvasive products estimating physiologic parameters (SpO2, BP, glucose). Reshapes the device / non-device line for AI wellness features.
Final guidance2025-09
Computer Software Assurance for Production and Quality Management System Software
SaMD (general) · Postmarket
Final (Sept 2025). Covers software used in production/QMS (incl. ML development-pipeline tooling), superseding Section 6 of the 2002 GPSV — not device software functions themselves.
Final guidance2025-06
Cybersecurity in Medical Devices: Quality Management System Considerations and Content of Premarket Submissions
Cybersecurity · Software premarket content
Reissued June 2025 (retitled 'Quality Management System', was Sept 2023 'Quality System'); adds coverage of FD&C Act §524B cyber devices.
Final guidance2024-12
Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial Intelligence-Enabled Device Software Functions
Predetermined Change Control Plan · AI/ML lifecycle · Software premarket content
Final (Dec 2024). Supersedes the April 2023 AI/ML PCCP draft.
Final guidance2023-10
Electronic Submission Template for Medical Device 510(k) Submissions
Software premarket content
eSTAR has been mandatory for 510(k)s since Oct 2023 — operationally unavoidable, though not AI-specific.
Final guidance2023-08
Off-The-Shelf Software Use in Medical Devices
Software premarket content · SaMD (general)
Final (Aug 2023). Applies when a device incorporates off-the-shelf software components (common in ML stacks).
Final guidance2023-06
Content of Premarket Submissions for Device Software Functions
Software premarket content · SaMD (general)
Final (June 2023); replaced the May 2005 'Software Contained in Medical Devices' guidance. Documentation level drives the software content of the submission.
Final guidance2022-09
Policy for Device Software Functions and Mobile Medical Applications
SaMD (general) · Clinical decision support
Current version Sept 2022. Frames which software functions FDA regulates as devices.
Final guidance2021-10
De Novo Classification Process (Evaluation of Automatic Class III Designation)
De Novo pathway
Final (Oct 2021), issued with the De Novo final rule. Most relevant to first-of-a-kind devices without a predicate (DEN-numbered clearances).
Final guidance2016-12
Postmarket Management of Cybersecurity in Medical Devices
Cybersecurity · Postmarket
Final guidance2002-01
General Principles of Software Validation
SaMD (general) · Software premarket content
Still active except Section 6 (superseded Sept 2025 by the Computer Software Assurance final guidance).
Draft guidance2025-01
Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations
AI/ML lifecycle · Software premarket content · Transparency
Draft as of July 2026 (published Jan 2025); finalization is on CDRH's FY2026 agenda but not yet published. Treat as FDA's stated direction, not a binding expectation.
Draft guidance2024-08
Predetermined Change Control Plans for Medical Devices
Predetermined Change Control Plan · Postmarket
Draft (Aug 2024) extending PCCPs beyond AI to all devices under FD&C §515C; not final as of July 2026.
Guiding principles2024-06
Transparency for Machine Learning-Enabled Medical Devices: Guiding Principles
Transparency · AI/ML lifecycle
Guiding principles2023-10
Predetermined Change Control Plans for Machine Learning-Enabled Medical Devices: Guiding Principles
Predetermined Change Control Plan · AI/ML lifecycle
FDA/Health Canada/MHRA joint principles (Oct 2023); companion to the GMLP and Transparency principles.
Guiding principles2021-10
Good Machine Learning Practice for Medical Device Development: Guiding Principles
AI/ML lifecycle · SaMD (general)
FDA/Health Canada/MHRA joint principles (Oct 2021). Foundational, not a binding guidance; IMDRF issued a related GMLP document Jan 2025.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.