Ceevra Reveal 3+

K243933

Ceevra, Inc. · cleared 2025-03-04 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“Ceevra Reveal 3+, as modified, (“Modified 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.6)
“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
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.8)
“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 “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions."”

Validation studies (2)

Retrospective clinical

n=133 cases

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 measurement features

Reported performance (12 observations)

diceas written: “prostate DSC (from MR prostate imaging)”0.9
source quote (p.9)
“prostate (from MR prostate imaging) 0.90 DSC”
diceas written: “bladder DSC (from MR prostate imaging)”0.93
source quote (p.9)
“bladder (from MR prostate imaging) 0.93 DSC”
diceas written: “kidney DSC (from CT abdomen imaging)”0.92
source quote (p.9)
“kidney (from CT abdomen imaging) 0.92 DSC”
diceas written: “kidney DSC (from MR abdomen imaging)”0.89
source quote (p.9)
“kidney (from MR abdomen imaging) 0.89 DSC”
diceas written: “artery DSC (from CT abdomen imaging)”0.9
source quote (p.9)
“artery (from CT abdomen imaging) 0.90 DSC”
diceas written: “artery DSC (from MR abdomen imaging)”0.87
source quote (p.9)
“artery (from MR abdomen imaging) 0.87 DSC”
diceas written: “vein DSC (from CT abdomen imaging)”0.88
source quote (p.9)
“vein (from CT abdomen imaging) 0.88 DSC”
diceas written: “vein DSC (from MR abdomen imaging)”0.82
source quote (p.9)
“vein (from MR abdomen imaging) 0.82 DSC”
diceas written: “pulmonary artery DSC (from CT chest imaging)”0.82
source quote (p.9)
“pulmonary artery (from CT chest imaging) 0.82 DSC”
diceas written: “pulmonary vein DSC (from CT chest imaging)”0.83
source quote (p.9)
“pulmonary vein (from CT chest imaging) 0.83 DSC”
diceas written: “airways DSC (from CT chest imaging)”0.82
source quote (p.9)
“airways (from CT chest imaging) 0.82 DSC”
diceas written: “bronchopulmonary segments DSC (from CT chest imaging)”0.86
source quote (p.9)
“bronchopulmonary segments (from CT chest imaging) 0.86 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
0
drift signals on this device

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/K243933