FDA 510(k)

FUJIFILM FC1 Ultrasound System

K-번호: K160406 · 2016-03-16

결정일2016-03-16

제품 코드IYN

자문 위원회RA

결정Substantially Equivalent

기기 요약

FUJIFILM FC1 Ultrasound System is the device name listed in this FDA 510(k) record. The listed applicant is FUJIFILM Sonosite, Inc.. It received FDA 510(k) clearance on 2016-03-16 under 510(k) number K160406. 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 FUJIFILM FC1 Ultrasound System?

FUJIFILM FC1 Ultrasound System is a medical device that received FDA 510(k) clearance on 2016-03-16. The listed applicant is FUJIFILM Sonosite, Inc.. The 510(k) number is K160406.

When did FUJIFILM FC1 Ultrasound System receive FDA 510(k) clearance?

FUJIFILM FC1 Ultrasound System received FDA 510(k) clearance on 2016-03-16, under 510(k) number K160406.

Who is the listed applicant for FUJIFILM FC1 Ultrasound System?

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

What is the FDA product code for FUJIFILM FC1 Ultrasound System?

The FDA product code for FUJIFILM FC1 Ultrasound System is IYN.

FUJIFILM Sonosite, Inc.를 신청인으로 등재한 기타 기록

K260595Sonosite iLOOK Ultrasound System K253448Sonosite MT Ultrasound System K251106Sonosite LX and Sonosite PX Ultrasound Systems K251830Sonosite LX Ultrasound System K233597Sonosite LX Ultrasound System K213763Sonosite PX Ultrasound System

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