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Perimeter Medical Imaging Ai, Inc.

FDA 510(k) & PMA Approved Devices — 2 products

Total Devices2
Categories2
Latest Approval2026-03-03
TypeNumberDevice NameCodeDate
PMA P250008 OCT imaging system with AI/ML software for adjunctive detection of breast cancer SHH 2026-03-03 View
510(k) K203578 OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System NQQ 2021-02-25 View