Data / Medical devices / Canada / Perimeter Medical Imaging Ai, Inc.
Perimeter Medical Imaging Ai, Inc.: FDA-registered device maker in Toronto Ontario, Canada, 1 510(k) clearance and 1 PMA approval
Perimeter Medical Imaging Ai, Inc. is registered with the FDA (registration 3013276158) in Toronto Ontario, Canada. It lists 2 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated March 3, 2026. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3013276158
- Address
- 555 Richmond St W Suite 511, Toronto Ontario, Canada, M5V 3B1
- Owner or operator
- Perimeter Medical Imaging AI (10052944)
- Roles
- Complaint file establishment, Specification developer
- First device listed
- March 1, 2021
- Registered through
- 2026
- Brand names listed
- B-Series OCT System, Claire OCT System, Perimeter OTIS 2.1 Optical Coherence Tomography System, Perimeter S-Series OCT, THiA
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Oct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast Cancer | SHH | 3 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| System, Imaging, Optical Coherence Tomography (Oct) | NQQ | 2 | Complaint file establishment, Specification developer | 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 |
|---|---|---|---|---|---|---|
| February 25, 2021 | K203578 | OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System | NQQ | Substantially Equivalent | Perimeter Medical Imaging Ai, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| March 3, 2026 | P250008 | Claire OCT System | SHH | 1 | August 10, 2026 | accessdata.fda.gov |
Compare with other makers
Updated August 10, 2026. 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.