Perimeter Medical Imaging Ai, Inc.: PMA supplement approved for Claire OCT System
Perimeter Medical Imaging Ai, Inc. (Toronto): PMA supplement approved for Claire OCT System. Dated 87 days ago, it serves as a historical benchmark. Score 30/100. As of 2026-11-05, from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration).
Data as of · Compiled by Zalwin from openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
Free preview: all 8 published fields of this record are shown below. Locked: 499 related FdaApprovalPulse records and the 4-column CSV export.
| Field | Value |
|---|---|
| Sponsor | Perimeter Medical Imaging Ai, Inc. |
| Product | Claire OCT System |
| Generic / ingredient | OCT imaging system with AI/ML software for adjunctive detection of breast cancer |
| Approval | PMA supplement (device change) |
| Application | P250008 S001 |
| Decided | 2026-08-10 |
| Panel / class | General, Plastic Surgery |
| Sponsor location | Toronto |
| Peer records CSV (500 records) | 🔒 Click to unlock → |
| CRM-ready export with official source URLs | 🔒 Click to unlock → |
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CSV columns: Sponsor · Product · Approval · Decided · official source URL
- Source agency: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration)
- Record date: 2026-08-10
- Data refreshed: 2026-11-05
- Refunds on request within 14 days
Top FdaApprovalPulse records: Instylla, Inc. · Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) · Cerenovus, Inc. · Advanced Medical Solutions Limited · Lenstec, Inc. · Browse all by state and category →
LIVE PUBLIC DATA Source: openFDA device PMA and Drugs@FDA endpoints (U.S. Food and Drug Administration) · Last refreshed: Thu, 05 Nov 2026 08:47:15 GMT
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30 / 100 Score
What is the FdaApprovalPulse record for Perimeter Medical Imaging Ai, Inc. in Toronto?
The FDA approved Claire OCT System (P250008 S001) for Perimeter Medical Imaging Ai, Inc. on 2026-08-10: PMA supplement (device change).
How does Perimeter Medical Imaging Ai, Inc. compare to other FdaApprovalPulse records?
It is 87 days old; check the official source for later updates before acting. Its Score of 30/100 is modest; treat it as background rather than a priority.
Perimeter Medical Imaging Ai, Inc. vs. top 3 peers
| Organization | Location | Record date |
|---|---|---|
| Perimeter Medical Imaging Ai, Inc. | Toronto | 2026-08-10 |
| Instylla, Inc. | Bedford, MA | 2026-10-23 |
| Ventana Medical Systems, Inc. (Roche Tissue Diagnostics) | Tucson, AZ | 2026-10-23 |
| Cerenovus, Inc. | Miami, FL | 2026-10-23 |
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✓ Read-only, live public data · Key and unlock right after payment · Card, Apple Pay, Google Pay or Link via Stripe · Refunds on request within 14 days
From openFDA (PMA and Drugs@FDA). openFDA can lag FDA decisions by days to weeks. Drug supplement types follow the FDA submission class (labeling and REMS, manufacturing/CMC, efficacy, other). Company and product level only. Verify on FDA databases before relying on an approval.