FDA 510(k)

ARIETTA Prologue 진단超음파 시스템 및 트랜스듀서

K-번호: K162902 · 2016-12-15

결정일2016-12-15

제품 코드IYN

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

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기기 요약

ARIETTA Prologue Diagnostic Ultrasound system and Transducers is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi , Ltd.. It received FDA 510(k) clearance on 2016-12-15 under 510(k) number K162902. 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 Prologue Diagnostic Ultrasound system and Transducers?

ARIETTA Prologue Diagnostic Ultrasound system and Transducers is a medical device that received FDA 510(k) clearance on 2016-12-15. The listed applicant is Hitachi , Ltd.. The 510(k) number is K162902.

When did ARIETTA Prologue Diagnostic Ultrasound system and Transducers receive FDA 510(k) clearance?

ARIETTA Prologue Diagnostic Ultrasound system and Transducers received FDA 510(k) clearance on 2016-12-15, under 510(k) number K162902.

Who is the listed applicant for ARIETTA Prologue Diagnostic Ultrasound system and Transducers?

The FDA 510(k) record lists Hitachi , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ARIETTA Prologue Diagnostic Ultrasound system and Transducers?

The FDA product code for ARIETTA Prologue Diagnostic Ultrasound system and Transducers is IYN.

Hitachi , Ltd.를 신청인으로 등재한 기타 기록

K201042PROBEAT-CR K191801PROBEAT-CR K172087SANGRAY K163505ARIETTA PRECISION K162583ALOKA LISENDO 880 K161163PROBEAT-V 프로τον 베이스 테라피 시스템 및 X선 제한 부속 장치

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