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FDA 510(k)

GSI Viewer with GSI Fat Option

K-Number: K180225 · 2018-04-24

ApplicantGE Medical Systems SCS
Decision Date2018-04-24
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GSI Viewer with GSI Fat Option is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems SCS. It received FDA 510(k) clearance on 2018-04-24 under 510(k) number K180225. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GSI Viewer with GSI Fat Option?

GSI Viewer with GSI Fat Option is a medical device that received FDA 510(k) clearance on 2018-04-24. The listed applicant is GE Medical Systems SCS. The 510(k) number is K180225.

When did GSI Viewer with GSI Fat Option receive FDA 510(k) clearance?

GSI Viewer with GSI Fat Option received FDA 510(k) clearance on 2018-04-24, under 510(k) number K180225.

Who is the listed applicant for GSI Viewer with GSI Fat Option?

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

What is the FDA product code for GSI Viewer with GSI Fat Option?

The FDA product code for GSI Viewer with GSI Fat Option is JAK.

Other records listing GE Medical Systems SCS as applicant

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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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