Ceevra, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Ceevra, Inc.” (first 2017, latest 2026), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 94 days. Since 2017 the median was 94 days, against 131 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2017 | 1 | 86 |
| 2018 | 1 | 271 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 2 | 130 |
| 2024 | 0 | — |
| 2025 | 1 | 74 |
| 2026 | 1 | 103 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ceevra, Inc. took a median 94 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 131 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QIH | Automated Radiological Image Processing Software | 4 | 4 |
| LLZ | System, Image Processing, Radiological | 2 | 2 |
Review panels
- Radiology (6)
Most recent Ceevra, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K261595 | Ceevra Reveal 4 | QIH | 2026-08-25 | 103 |
| K243933 | Ceevra Reveal 3+ | QIH | 2025-03-04 | 74 |
| K233568 | Ceevra Reveal 3+ | QIH | 2023-12-05 | 29 |
| K222676 | Ceevra Reveal 3 | QIH | 2023-04-25 | 231 |
| K173274 | Ceevra Reveal 2.0 | LLZ | 2018-07-10 | 271 |
| K171356 | Clarity Reveal | LLZ | 2017-08-03 | 86 |
Recalls
openFDA lists no recalls under a recalling firm named Ceevra, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Device clinical trials
An industry sponsor named Ceevra, Inc. is the lead sponsor of 3 device studies on ClinicalTrials.gov (0 active or recruiting). Most recent:
- NCT03870269: Using Virtual Reality (VR) Models for Robotic Prostatectomy - UNC (Completed, started 2019-02-25)
- NCT03943368: Using Virtual Reality (VR) Models for Robotic Prostatectomy (Completed, started 2019-01-01)
- NCT03334344: Using Virtual Reality (VR) Models for Preoperative Planning (Completed, started 2017-10-24)
Frequently asked questions
How many FDA 510(k) clearances are listed under Ceevra, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Ceevra, Inc.” (first 2017, latest 2026), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Ceevra, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ceevra, Inc. is 94 days. Since 2017: 94 days, versus 131 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ceevra, Inc.?
The most frequent FDA product codes under this applicant name are QIH (Automated Radiological Image Processing Software, 4); LLZ (System, Image Processing, Radiological, 2).
Next steps
- See all 6 Ceevra, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QIH, Ceevra, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.