FDA 510(k)

QT Scanner 2000 Model A

K-번호: K253898 · 2026-03-04

결정일2026-03-04

제품 코드IYO

자문 위원회RA

결정Substantially Equivalent

기기 요약

QT Scanner 2000 Model A is the device name listed in this FDA 510(k) record. The listed applicant is QT Imaging Holdings, Inc.. It received FDA 510(k) clearance on 2026-03-04 under 510(k) number K253898. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the QT Scanner 2000 Model A?

QT Scanner 2000 Model A is a medical device that received FDA 510(k) clearance on 2026-03-04. The listed applicant is QT Imaging Holdings, Inc.. The 510(k) number is K253898.

When did QT Scanner 2000 Model A receive FDA 510(k) clearance?

QT Scanner 2000 Model A received FDA 510(k) clearance on 2026-03-04, under 510(k) number K253898.

Who is the listed applicant for QT Scanner 2000 Model A?

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

What is the FDA product code for QT Scanner 2000 Model A?

The FDA product code for QT Scanner 2000 Model A is IYO.

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QT Scanner 2000 Model A

기기 요약

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관련 임상시험

관련 기기 (코드: IYO)

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