Chrysalis Intelligence · Sponsors · Perimeter Medical Imaging Ai, Inc.

Perimeter Medical Imaging Ai, Inc.

Toronto, CA · 1 510(k) clearances · 2 PMAs

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Total clearances
1
2021-02-25 → 2021-02-25
Last 12 months
0
Product codes
1
Most recent
2021-02-25
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
NQQ System, Imaging, Optical Coherence Tomography (Oct) Class II Radiology 1 2021-02-25
Class III

PMA approvals (2)

Total PMA records
2
Originals + supplements
Distinct product codes
1
First decision
2026-03-03
Most recent
2026-08-10
DatePMA #Trade nameTypeCodeDevice nameSpecialty
2026-08-10 P250008-S001 Claire™ OCT System Normal 180 Day Track No User Fee SHH Oct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast Cancer Unknown
2026-03-03 P250008 Claire™ OCT System Original SHH Oct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast Cancer Unknown
Filings

All 510(k) clearances (1)

Date K-number Device Code Class Specialty
2021-02-25 K203578 OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System NQQ Class II Radiology
Data source: openFDA · Generated 2026-08-26 09:36 · Last ingest 2026-08-26T13:35:45.365163 · Pipeline: Chrysalis Intelligence