Ceevra Reveal 3
K222676Ceevra, Inc. · cleared 2023-04-25 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.5)
“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.”
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.”
source quote (p.3)
“The machine learning algorithms in use by Ceevra Reveal 3 are for use only for adult patients (22 and over). Three-dimensional images for patients under the age of 22 or of unknown age will be generated without the use of any machine learning algorithms.”
source quote (p.7)
“Content of Premarket Submission for Management of Cybersecurity in Medical Devices.”
Validation studies (1)
Retrospective clinical
n=141 images
endpoints: Sørensen-Dice coefficient (DSC); Hausdorff distance metric at the 95th percentile (HD-95)
standards: IEC 62304:2006/Amd 1: 2015, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, Content of Premarket Submission for Management of Cybersecurity in Medical Devices.
Reported performance (10 observations)
source quote (p.7)
“prostate (from MR prostate imaging) 0.87 DSC”
source quote (p.7)
“bladder (from MR prostate imaging) 0.90 DSC”
source quote (p.7)
“kidney (from CT abdomen imaging) 0.89 DSC”
source quote (p.7)
“kidney (from MR abdomen imaging) 0.87 DSC”
source quote (p.7)
“artery (from CT abdomen imaging) 0.87 DSC”
source quote (p.7)
“artery (from MR abdomen imaging) 0.83 DSC”
source quote (p.7)
“vein (from CT abdomen imaging) 0.86 DSC”
source quote (p.7)
“vein (from MR abdomen imaging) 0.81 DSC”
source quote (p.7)
“artery (from CT chest imaging) 0.85 DSC”
source quote (p.7)
“vein (from CT chest imaging) 0.81 DSC”
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
- 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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K233568 (decision 2023-12-05) 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:K233568
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). 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).