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FDA 510(k)

Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1

K-Number: K153206 · 2016-03-03

ApplicantFujifilm Medical System U.S.A., Inc.
Decision Date2016-03-03
Product CodeFDS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 is a medical device manufactured by Fujifilm Medical System U.S.A., Inc.. It received FDA 510(k) clearance on 2016-03-03 under approval number K153206. The device is classified under product code FDS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1?

Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 is a medical device that received FDA 510(k) clearance on 2016-03-03. It is manufactured by Fujifilm Medical System U.S.A., Inc.. The 510(k) number is K153206.

When was Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 approved by the FDA?

Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 received FDA 510(k) clearance on 2016-03-03, under approval number K153206.

What company makes Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1?

Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 is manufactured by Fujifilm Medical System U.S.A., Inc..

What is the FDA product code for Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1?

The FDA product code for Fujifilm Ultrasonic Processors SU-1 PLATINUM and SU-1 is FDS.

Other Devices by Fujifilm Medical System U.S.A., Inc.

K151474Fujifilm Diathermic Slitter (FlushKnife), Diathermic Slitter (ClutchCutter) K163675Processor VP-7000, Light Source BL-7000

Related Devices (Code: FDS)

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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