FDA 510(k)

ARIETTA x10

K-번호: K231941 · 2023-11-20

신청자FUJIFILM Healthcare Americas Corporation

결정일2023-11-20

제품 코드IYN

자문 위원회RA

결정Substantially Equivalent

기기 요약

ARIETTA x10 is the device name listed in this FDA 510(k) record. The listed applicant is FUJIFILM Healthcare Americas Corporation. It received FDA 510(k) clearance on 2023-11-20 under 510(k) number K231941. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the ARIETTA x10?

ARIETTA x10 is a medical device that received FDA 510(k) clearance on 2023-11-20. The listed applicant is FUJIFILM Healthcare Americas Corporation. The 510(k) number is K231941.

When did ARIETTA x10 receive FDA 510(k) clearance?

ARIETTA x10 received FDA 510(k) clearance on 2023-11-20, under 510(k) number K231941.

Who is the listed applicant for ARIETTA x10?

The FDA 510(k) record lists FUJIFILM Healthcare Americas Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARIETTA x10?

The FDA product code for ARIETTA x10 is IYN.

FUJIFILM Healthcare Americas Corporation를 신청인으로 등재한 기타 기록

K261713Synapse PACS (7.6.0)K251204FUJIFILM 강화선 장치 (SW-2000)K243647Synapse PACS (7.5)K233321중량 balloon endoscope EN-840T, Over-tube TS-1214C K233629APERTO Lucent MRI System K233687에셀론 시너지 V10.0

13개 장치 모두 보기 →

관련 기기 (코드: IYN)

공식 출처

FDA 데이터베이스에서 보기 →

FDA Open API에서 수집된 데이터입니다. 가장 정확하고 공인된 정보는 항상 공식 레코드를 참조하시기 바랍니다.