| Primary Device ID | 00086162500046 |
| NIH Device Record Key | 3c1e8e8a-2b81-40aa-b8ed-b23251b07677 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | Reveal 2.0 |
| Version Model Number | 2.10 |
| 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 |
| Phone | 415-325-4830 |
| support@ceevra.com | |
| Phone | 415-325-4830 |
| support@ceevra.com | |
| Phone | 415-325-4830 |
| support@ceevra.com | |
| Phone | 415-325-4830 |
| support@ceevra.com | |
| Phone | 415-325-4830 |
| support@ceevra.com | |
| Phone | 415-325-4830 |
| support@ceevra.com | |
| Phone | 415-325-4830 |
| support@ceevra.com | |
| Phone | 415-325-4830 |
| support@ceevra.com | |
| Phone | 415-325-4830 |
| support@ceevra.com | |
| Phone | 415-325-4830 |
| support@ceevra.com | |
| Phone | 415-325-4830 |
| support@ceevra.com | |
| Phone | 415-325-4830 |
| support@ceevra.com | |
| Phone | 415-325-4830 |
| support@ceevra.com | |
| Phone | 415-325-4830 |
| support@ceevra.com | |
| Phone | 415-325-4830 |
| support@ceevra.com | |
| Phone | 415-325-4830 |
| support@ceevra.com | |
| Phone | 415-325-4830 |
| support@ceevra.com |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00086162500046 [Primary] |
| LLZ | System, Image Processing, Radiological |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2023-07-17 |
| Device Publish Date | 2023-07-07 |
| 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 | 2023-07-17Ceevra Reveal 2.0 is a software-only device that allows clinicians to review CT and MR image data in three-dimensional (3D) format and/or stereoscopic 3D format (commonly known as virtual reality, or VR). The 3D and VR images are accessible through the Ceevra Reveal 2.0 mobile application which is used by clinicians for preoperative surgical planning and to support intraoperative decision making. Ceevra Reveal 2.0 includes two main software-based user interface components, the Processing Interface and Viewer Interface. The Processing Interface is hosted on a cloud-based, virtual workstation and only accessed by authorized personnel, such as an imaging technician. The Processing Interface contains a graphical user interface where an imaging technician can select DICOM-compatible medical images, segment such images, and initiate processing into a 3D format. The Viewer Interface is a mobile application that is accessible via a compatible, touchscreen enabled, off-the-shelf mobile device to allow for clinicians to review the medical images in 3D and/or VR formats. Only when the compatible mobile device is used in conjunction with a compatible off-the-shelf VR headset can the surgeon view medical images in the VR format. The product is intended to be used by trained medical professionals, including imaging technicians and clinicians/surgeons, and is used to assist in clinical decision making. |
| 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 |