Data / Medical devices / United States / Ceevra, Inc.
Ceevra, Inc.: FDA-registered device maker in San Francisco, CA, United States, 5 510(k) clearances
Ceevra, Inc. is registered with the FDA (registration 3014132130) in San Francisco, CA, United States. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated March 4, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014132130
- Address
- 465 California St Fl 7, San Francisco, CA, United States, 94104
- Owner or operator
- Ceevra, Inc. (10056233)
- Roles
- Manufacturer
- First device listed
- November 19, 2017
- Registered through
- 2026
- Brand names listed
- Ceevra Reveal, Ceevra Reveal 3, Ceevra Reveal 3+, Reveal 1, Reveal 2
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 4, 2025 | K243933 | Ceevra Reveal 3+ | QIH | Substantially Equivalent | Ceevra, Inc. | accessdata.fda.gov |
| December 5, 2023 | K233568 | Ceevra Reveal 3+ | QIH | Substantially Equivalent | Ceevra, Inc. | accessdata.fda.gov |
| April 25, 2023 | K222676 | Ceevra Reveal 3 | QIH | Substantially Equivalent | Ceevra, Inc. | accessdata.fda.gov |
| July 10, 2018 | K173274 | Ceevra Reveal 2.0 | LLZ | Substantially Equivalent | Ceevra, Inc. | accessdata.fda.gov |
| August 3, 2017 | K171356 | Clarity Reveal | LLZ | Substantially Equivalent | Ceevra, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Automated Radiological Image Processing Software
- All makers of System, Image Processing, Radiological
Updated March 4, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.