FDA PMA

AI/MLソフトウェアを用いた乳がんの併用検出のためのOCT画像システム

PMA番号：P250008 · 2026-08-10

申請者Perimeter Medical Imaging Ai, Inc.

決定日2026-08-10

PMA番号P250008

製品コードSHH

デバイスクラスクラス3

診療科U

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

医療機器の概要

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.

よくある質問

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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医療機器の概要

よくある質問

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