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FDA 510(k)

FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M

K-Number: K171207 · 2018-01-11

ApplicantFujifilm Medical Systems U.S.A, Inc.
Decision Date2018-01-11
Product CodeODG
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M is a medical device manufactured by Fujifilm Medical Systems U.S.A, Inc.. It received FDA 510(k) clearance on 2018-01-11 under approval number K171207. The device is classified under product code ODG. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M?

FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M is a medical device that received FDA 510(k) clearance on 2018-01-11. It is manufactured by Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K171207.

When was FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M approved by the FDA?

FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M received FDA 510(k) clearance on 2018-01-11, under approval number K171207.

What company makes FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M?

FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M is manufactured by Fujifilm Medical Systems U.S.A, Inc..

What is the FDA product code for FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M?

The FDA product code for FUJIFILM Ultrasonic Processor SP-900 and FUJIFILM Ultrasonic Probe PB2020-M is ODG.

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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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