FDA 510(k)

ACUSON S1000/S2000/S3000 진단 초음파 시스템

K-번호: K163635 · 2017-01-12

신청자Siemens Medical Solutions USA, Inc. Ultrasound Group

결정일2017-01-12

제품 코드IYN

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

결정대체적으로 동일

기기 요약

ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc. Ultrasound Group. It received FDA 510(k) clearance on 2017-01-12 under 510(k) number K163635. 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 ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems?

ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems is a medical device that received FDA 510(k) clearance on 2017-01-12. The listed applicant is Siemens Medical Solutions USA, Inc. Ultrasound Group. The 510(k) number is K163635.

When did ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems receive FDA 510(k) clearance?

ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems received FDA 510(k) clearance on 2017-01-12, under 510(k) number K163635.

Who is the listed applicant for ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc. Ultrasound Group as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems?

The FDA product code for ACUSON S1000/S2000/S3000 Diagnostic Ultrasound Systems is IYN.

Siemens Medical Solutions USA, Inc. Ultrasound Group를 신청인으로 등재한 기타 기록

K173981ACUSON NX2 진단 초음파 시스템, ACUSON NX2 Elite 진단 초음파 시스템

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