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FDA PMA

OCT imaging system with AI/ML software for adjunctive detection of breast cancer

Numéro PMA : P250008 · 2026-08-10

DemandeurPerimeter Medical Imaging Ai, Inc.
Date de décision2026-08-10
Numéro PMAP250008
Code produitSHH
Classe de dispositifClasse 3
Spécialité médicaleU
Comité consultatifSU

Résumé du dispositif

OCT imaging system with AI/ML software for adjunctive detection of breast cancer is the device name listed in this FDA 510(k) record. The listed applicant is Perimeter Medical Imaging Ai, Inc.. It received FDA 510(k) clearance on 2026-08-10. The device is classified under product code SHH. It was reviewed by the SU advisory panel.

Questions fréquentes

What is the OCT imaging system with AI/ML software for adjunctive detection of breast cancer?

OCT imaging system with AI/ML software for adjunctive detection of breast cancer is a medical device that received FDA 510(k) clearance on 2026-08-10. The listed applicant is Perimeter Medical Imaging Ai, Inc..

When did OCT imaging system with AI/ML software for adjunctive detection of breast cancer receive FDA 510(k) clearance?

The clearance date for OCT imaging system with AI/ML software for adjunctive detection of breast cancer can be found in the official FDA records.

Who is the listed applicant for OCT imaging system with AI/ML software for adjunctive detection of breast cancer?

The FDA 510(k) record lists Perimeter Medical Imaging Ai, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OCT imaging system with AI/ML software for adjunctive detection of breast cancer?

The FDA product code for OCT imaging system with AI/ML software for adjunctive detection of breast cancer is SHH.

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Source officielle

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