ARTAssistant

Validation studies (3)

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

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

• predicate_cohort_contagion

  K250780 shares predicate K220141 with K222312 (RayStation 12A), whose product code MUJ recorded 35 recall event(s) in the trailing 24 months.

  first seen 2026-07-15 · predicate:K220141 sibling:K222312

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 2026-08-26.

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.