FDA 510(k)

AspenView

K-번호: K241425 · 2025-02-12

결정일2025-02-12

제품 코드LLZ

자문 위원회[원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

AspenView is the device name listed in this FDA 510(k) record. The listed applicant is Aspen Imaging Healthcare, Inc.. It received FDA 510(k) clearance on 2025-02-12 under 510(k) number K241425. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the AspenView?

AspenView is a medical device that received FDA 510(k) clearance on 2025-02-12. The listed applicant is Aspen Imaging Healthcare, Inc.. The 510(k) number is K241425.

When did AspenView receive FDA 510(k) clearance?

AspenView received FDA 510(k) clearance on 2025-02-12, under 510(k) number K241425.

Who is the listed applicant for AspenView?

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

What is the FDA product code for AspenView?

The FDA product code for AspenView is LLZ.

Aspen Imaging Healthcare, Inc.를 신청인으로 등재한 기타 기록

K241346IODR1717 / IODR1417 / IODR1417-GF (디지털 평면 X선探测器)

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