Ceevra Reveal 3+
K243933Ceevra, 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.4)
“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.4)
“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.”
PCCPNo
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 (1)
Retrospective clinical
n=133 images
standards: IEC 62304:2006/Amd 1: 2015- Medical device software – Software life cycle processes
Reported performance (12 observations)
diceas written: “prostate DSC”0.9
source quote (p.9)
“prostate (from MR prostate imaging) 0.90 DSC”
diceas written: “bladder DSC”0.93
source quote (p.9)
“bladder (from MR prostate imaging) 0.93 DSC”
diceas written: “kidney DSC (CT abdomen)”0.92
source quote (p.9)
“kidney (from CT abdomen imaging) 0.92 DSC”
diceas written: “kidney DSC (MR abdomen)”0.89
source quote (p.9)
“kidney (from MR abdomen imaging) 0.89 DSC”
diceas written: “artery DSC (CT abdomen)”0.9
source quote (p.9)
“artery (from CT abdomen imaging) 0.90 DSC”
diceas written: “artery DSC (MR abdomen)”0.87
source quote (p.9)
“artery (from MR abdomen imaging) 0.87 DSC”
diceas written: “vein DSC (CT abdomen)”0.88
source quote (p.9)
“vein (from CT abdomen imaging) 0.88 DSC”
diceas written: “vein DSC (MR abdomen)”0.82
source quote (p.9)
“vein (from MR abdomen imaging) 0.82 DSC”
diceas written: “pulmonary artery DSC (CT chest)”0.82
source quote (p.9)
“pulmonary artery (from CT chest imaging) 0.82 DSC”
diceas written: “pulmonary vein DSC (CT chest)”0.83
source quote (p.9)
“pulmonary vein (from CT chest imaging) 0.83 DSC”
diceas written: “airways DSC (CT chest)”0.82
source quote (p.9)
“airways (from CT chest imaging) 0.82 DSC”
diceas written: “bronchopulmonary segments DSC (CT chest)”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). 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).