FDA PMA

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

Номер PMA: P250008 · 2026-08-10

ЗаявительPerimeter Medical Imaging Ai, Inc.

Дата решения2026-08-10

Номер PMAP250008

Код продуктаSHH

Класс устройстваКласс 3

Медицинская специализацияU

Консультативный комитетSU

Описание устройства

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.

Часто задаваемые вопросы

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.

Связанные клинические исследования

Связанные записи сопоставляются автоматически на основании названий, кодов продукции или иных метаданных. Сопоставление не подтверждает клиническую, научную, корпоративную или регуляторную связь; ознакомьтесь с официальными источниками по ссылкам.

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Официальный источник

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