Ceevra Reveal 3

K222676

Ceevra, Inc. · cleared 2023-04-25 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
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.”
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)FDA source did not state this
PCCPNo
Cybersecurity addressedYes
source quote (p.7)
“Content of Premarket Submission for Management of Cybersecurity in Medical Devices.”

Validation studies (1)

Retrospective clinical

n=141 patients

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

standards: 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)

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”

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
2
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

  • 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); 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/K222676