FDA 510(k)

Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1

K-번호: K170177 · 2017-06-30

결정일2017-06-30

제품 코드JAK

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

결정대체적으로 동일

기기 요약

Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1 is the device name listed in this FDA 510(k) record. The listed applicant is Toshibamedical Systems Corporation. It received FDA 510(k) clearance on 2017-06-30 under 510(k) number K170177. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1?

Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1 is a medical device that received FDA 510(k) clearance on 2017-06-30. The listed applicant is Toshibamedical Systems Corporation. The 510(k) number is K170177.

When did Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1 receive FDA 510(k) clearance?

Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1 received FDA 510(k) clearance on 2017-06-30, under 510(k) number K170177.

Who is the listed applicant for Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1?

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

What is the FDA product code for Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1?

The FDA product code for Aquilion ONE (TSX-305A/3) V8.3 with FIRST 2.1 is JAK.

Toshibamedical Systems Corporation를 신청인으로 등재한 기타 기록

K173962Viamo c100 TUS-VC100 진단 초음파 시스템 K173468Aquilion Precision (TSX-304A/2) V8.6 with FIRST 3.0 K173088비테라 소프트웨어 터시나 패키지 VSTP-001A K173382Vantage Galan 3T, V4.6 K173090Aplio i900/i800/i700/i600 진단 초음파 시스템, V2.4 K172863Infinix-i, INFX-8000V, V7.0

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