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Reveal Family
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref Reveal 3
by Ceevra, Inc.
Identity
- Trade Name
- Ceevra Reveal 3+ FDA UDI
- Generic Name
- Image segmentation application software FDA UDI
- Device Name
- Reveal Family EUDAMEDCeevra 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. Clinicians view 3D images via the Reveal 3+ Mobile Image Viewer software application which runs on compatible mobile devices, and the Reveal 3+ Desktop Image Viewer software application which runs on compatible computers. The 3D images may also be displayed on compatible external displays, or in virtual reality (VR) format with a compatible off-the-shelf VR headset. Reveal 3+ includes features that enable clinicians to interact with the 3D images including rotating, zooming, panning, selectively showing or hiding individual anatomical structures, and viewing measurements of or between anatomical structures. FDA UDI
- Model / Reference
- Reveal 3 EUDAMED3+ FDA UDI
- Description
- 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. Clinicians view 3D images via the Reveal 3+ Mobile Image Viewer software application which runs on compatible mobile devices, and the Reveal 3+ Desktop Image Viewer software application which runs on compatible computers. The 3D images may also be displayed on compatible external displays, or in virtual reality (VR) format with a compatible off-the-shelf VR headset. Reveal 3+ includes features that enable clinicians to interact with the 3D images including rotating, zooming, panning, selectively showing or hiding individual anatomical structures, and viewing measurements of or between anatomical structures. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00861625000437 EUDAMEDFDA UDI
- Basic UDI-DI
- 08616250004reveal3A EUDAMED
- FDA Product Code
- QIH FDA UDI
- EMDN Code
- Z11069092 VARIOUS DIGITAL BIOIMAGING MANAGEMENT INSTRUMENTS - MEDICAL DEVICE SOFTWARE EUDAMED
- GMDN Term
- Image segmentation application software FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 892.2050 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
No
FDA UDI
Reveal Family by Ceevra, Inc. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K243933 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K222676 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K233568 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 08616250004reveal3A | Class IIa | Active |
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Manufacturer
- Manufacturer
- Ceevra, Inc.
- EUDAMED SRN
- US-MF-000042119
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (3)
- EUDAMED c2df2bac-13ed-4d46-a6c2-6704b97cabc2 61 fields · synced Jun 19, 2026
- FDA UDI 022618ce-395b-4c9a-8e78-7e6755833469 34 fields · synced May 30, 2026
- FDA 510(k) K243933 1 fields · synced May 18, 2026