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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / March 2026 / P250008

PMA approved

Claire OCT System

Perimeter Medical Imaging Ai, Inc. · Mar 3, 2026 · P250008 · In the directory

FDA approved the Claire OCT System from Perimeter Medical Imaging Ai, Inc. on Mar 3, 2026 under P250008, an original premarket approval. The device falls under product code SHH, Oct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast Cancer as a Class 3 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Mar 13, 2025. The decision came 355 days later.

This is the only decision on file for Perimeter Medical Imaging Ai, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA approve under P250008?

P250008 is the FDA PMA for Claire OCT System, submitted by Perimeter Medical Imaging Ai, Inc.. FDA's decision date was Mar 3, 2026, under product code SHH (Oct Imaging System With Ai/Ml Software For Adjunctive Detection Of Breast Cancer).

Who makes the Claire OCT System?

Perimeter Medical Imaging Ai, Inc., based in Toronto, is the applicant of record for P250008. The company is listed in the MedDevice Startups directory.

How long did the P250008 review take?

FDA received the submission on Mar 13, 2025 and issued its decision on Mar 3, 2026, 355 days later.

← All decisions in March 2026

Claire OCT System

OUR COVERAGE

Questions & Answers

What did FDA approve under P250008?

Who makes the Claire OCT System?

How long did the P250008 review take?

Claire OCT System

Who makes the Claire OCT System?