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FDA 510(k)

GSI VIEWER WITH VUE OPTION

K-Number: K121827 · 2012-09-13

ApplicantGE Medical Systems SCS
Decision Date2012-09-13
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GSI VIEWER WITH VUE 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 2012-09-13 under 510(k) number K121827. 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 VUE OPTION?

GSI VIEWER WITH VUE OPTION is a medical device that received FDA 510(k) clearance on 2012-09-13. The listed applicant is GE Medical Systems SCS. The 510(k) number is K121827.

When did GSI VIEWER WITH VUE OPTION receive FDA 510(k) clearance?

GSI VIEWER WITH VUE OPTION received FDA 510(k) clearance on 2012-09-13, under 510(k) number K121827.

Who is the listed applicant for GSI VIEWER WITH VUE 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 VUE OPTION?

The FDA product code for GSI VIEWER WITH VUE OPTION is JAK.

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Other records listing GE Medical Systems SCS as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: JAK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261125BodyTom 64 (NL4100); OmniTom Elite (NL5000)Samsung HME America, Inc., dba NeuroLogica Corp.K261229SCENARIA View Phase 6.0Fujifilm CorporationK253836FCT iStream Phase 2Fujifilm CorporationK253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLC

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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