Ceevra Reveal 3+

K233568

Ceevra, Inc. · cleared 2023-12-05 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“Ceevra Reveal 3+ (“Reveal 3+'), manufactured by Ceevra, Inc. (the "Company"), is a software as a medical device with two main functions: (1) it is used by Company personnel to generate three-dimensional (3D) images from existing patient CT and MR imaging, and (2) it is used by clinicians to view and interact with the 3D images during preoperative planning and intraoperatively.”
Algorithmmachine learning and other computer vision algorithms
source quote (p.3)
“Ceevra Reveal 3+ is intended as a medical imaging system that allows the processing, review, analysis, communication and media interchange of multi-dimensional digital images acquired from CT or MR imaging devices and that such processing may include the generation of preliminary segmentations of normal anatomy using software that employs machine learning and other computer vision algorithms.”
Adaptive (vs locked)No
source quote (p.6)
“No imaging study used to verify performance was used for training; independence of training and testing data were enforced at the level of the scanning institution, namely, studies sourced from a specific institution were used for either training or testing but could not be used for both.”
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.6)
“Additionally, the software validation activities were performed in accordance with IEC 62304:2006/Amd 1: 2015- Medical device software – Software life cycle processes, in addition to the FDA Guidance documents, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices” and “Content of Premarket Submission for Management of Cybersecurity in Medical Devices.””

Validation studies (2)

Standalone

n=141 images

endpoints: Sørensen-Dice coefficient (DSC); Hausdorff distance metric at the 95th percentile (HD-95)

standards: IEC 62304:2006/Amd 1: 2015- Medical device software – Software life cycle processes

Bench

sample size not stated

endpoints: accuracy of volumes of structures; accuracy of diameters of structures; accuracy of distances between two points

Reported performance (11 observations)

diceas written: “prostate (from MR prostate imaging) DSC”0.87
source quote (p.7)
“prostate (from MR prostate imaging) 0.87 DSC”
diceas written: “bladder (from MR prostate imaging) DSC”0.9
source quote (p.7)
“bladder (from MR prostate imaging) 0.90 DSC”
diceas written: “kidney (from CT abdomen imaging) DSC”0.89
source quote (p.7)
“kidney (from CT abdomen imaging) 0.89 DSC”
diceas written: “kidney (from MR abdomen imaging) DSC”0.87
source quote (p.7)
“kidney (from MR abdomen imaging) 0.87 DSC”
diceas written: “artery (from CT abdomen imaging) DSC”0.87
source quote (p.7)
“artery (from CT abdomen imaging) 0.87 DSC”
diceas written: “artery (from MR abdomen imaging) DSC”0.83
source quote (p.7)
“artery (from MR abdomen imaging) 0.83 DSC”
diceas written: “vein (from CT abdomen imaging) DSC”0.86
source quote (p.7)
“vein (from CT abdomen imaging) 0.86 DSC”
diceas written: “vein (from MR abdomen imaging) DSC”0.81
source quote (p.7)
“vein (from MR abdomen imaging) 0.81 DSC”
diceas written: “artery (from CT chest imaging) DSC”0.85
source quote (p.7)
“artery (from CT chest imaging) 0.85 DSC”
diceas written: “vein (from CT chest imaging) DSC”0.81
source quote (p.7)
“vein (from CT chest imaging) 0.81 DSC.”
f1as written: “accuracy of measurement features (mean difference)”10CI +/- 10%
source quote (p.7)
“All three types of measurements produced by Ceevra Reveal 3+ were verified to be accurate within a mean difference of +/- 10%.”

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

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
1
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K243933 (decision 2025-03-04) from Ceevra, Inc. for a matching device line ("Ceevra Reveal 3+") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K243933

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.

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.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K233568