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FDA 510(k)

CT COLONOGRAPHY/NAVIGATOR2

K-Number: K012313 · 2001-08-07

ApplicantGe Medical Systems, Inc.
Decision Date2001-08-07
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CT COLONOGRAPHY/NAVIGATOR2 is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems, Inc.. It received FDA 510(k) clearance on 2001-08-07 under 510(k) number K012313. 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 CT COLONOGRAPHY/NAVIGATOR2?

CT COLONOGRAPHY/NAVIGATOR2 is a medical device that received FDA 510(k) clearance on 2001-08-07. The listed applicant is Ge Medical Systems, Inc.. The 510(k) number is K012313.

When did CT COLONOGRAPHY/NAVIGATOR2 receive FDA 510(k) clearance?

CT COLONOGRAPHY/NAVIGATOR2 received FDA 510(k) clearance on 2001-08-07, under 510(k) number K012313.

Who is the listed applicant for CT COLONOGRAPHY/NAVIGATOR2?

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

What is the FDA product code for CT COLONOGRAPHY/NAVIGATOR2?

The FDA product code for CT COLONOGRAPHY/NAVIGATOR2 is JAK.

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Other records listing Ge Medical Systems, Inc. as applicant

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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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