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FDA PMA

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

Número do PMA: P250008 · 2026-08-10

RequerentePerimeter Medical Imaging Ai, Inc.
Data da decisão2026-08-10
Número PMAP250008
Código do produtoSHH
Classe do DispositivoClasse 3
Especialidade MédicaU
Comité consultivoSU

Resumo do dispositivo

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.

Perguntas frequentes

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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