Perimeter Medical Imaging Ai, Inc.: FDA filings under this applicant name
FDA lists 1 510(k) clearance under the applicant name “Perimeter Medical Imaging Ai, Inc.” (first 2021, latest 2021), plus 1 PMA decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 80 days. 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 |
|---|---|---|
| 2021 | 1 | 80 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Perimeter Medical Imaging Ai, Inc. took a median 80 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 88 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| NQQ | System, Imaging, Optical Coherence Tomography (Oct) | 1 | 1 |
| SHH | Oct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast Cancer | 1 | 0 |
Review panels
Most recent Perimeter Medical Imaging Ai, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K203578 | OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System | NQQ | 2021-02-25 | 80 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| P250008 | PMA | Claire OCT System | 2026-03-03 |
Recalls
openFDA lists no recalls under a recalling firm named Perimeter Medical Imaging Ai, 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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Perimeter Medical, Inc. (5 510(k)s)
- Perimeter Medical Imaging, Inc. (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Perimeter Medical Imaging Ai, Inc.?
FDA lists 1 510(k) clearance under the applicant name “Perimeter Medical Imaging Ai, Inc.” (first 2021, latest 2021), plus 1 PMA decision, 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 Perimeter Medical Imaging Ai, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Perimeter Medical Imaging Ai, Inc. is 80 days.
Which FDA product codes appear under Perimeter Medical Imaging Ai, Inc.?
The most frequent FDA product codes under this applicant name are NQQ (System, Imaging, Optical Coherence Tomography (Oct), 1); SHH (Oct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast Cancer, 1).
Next steps
- See all 1 Perimeter Medical Imaging Ai, Inc. clearances with predicates and recalls
- Run predicate analysis for product code NQQ, Perimeter Medical Imaging Ai, 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.