Ceevra Reveal 3+

GUDID 00861625000437

Image segmentation application software

Primary Device ID	00861625000437
NIH Device Record Key	022618ce-395b-4c9a-8e78-7e6755833469
Commercial Distribution Status	In Commercial Distribution
Brand Name	Ceevra Reveal 3+
Version Model Number	3+
Company DUNS	080408583
Company Name	Ceevra, Inc.
Device Count	1
DM Exempt	false
Pre-market Exempt	false
MRI Safety Status	Labeling does not contain MRI Safety Information
Human Cell/Tissue Product	false
Device Kit	false
Device Combination Product	false
Single Use	false
Lot Batch	false
Serial Number	false
Manufacturing Date	false
Expiration Date	false
Donation Id Number	false
Contains Natural Rubber Latex	false
Labeled No Natural Rubber Latex	false
RX Perscription	true
OTC Over-The-Counter	false

Device Issuing Agency	Device ID
GS1	00861625000437 [Primary]

QIH	Automated Radiological Image Processing Software

Steralize Prior To Use	false
Device Is Sterile	false

00861625000437 - Ceevra Reveal 3+	2024-08-19Ceevra 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.
00861625000437 - Ceevra Reveal 3+	2024-08-19 Ceevra Reveal 3+ (“Reveal 3+”), manufactured by Ceevra, Inc. (the “Company”), is a software as a medical device with two
00086162500046 - Reveal 2.0	2023-07-17 Ceevra Reveal 2.0 is a software-only device that allows clinicians to review CT and MR image data in three-dimensional (3D) form