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FDA 510(k)

CT COLONOGRAPHY

K-Number: K023943 · 2003-05-06

ApplicantGe Medical Systems, Inc.
Decision Date2003-05-06
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CT COLONOGRAPHY 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 2003-05-06 under 510(k) number K023943. 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?

CT COLONOGRAPHY is a medical device that received FDA 510(k) clearance on 2003-05-06. The listed applicant is Ge Medical Systems, Inc.. The 510(k) number is K023943.

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

CT COLONOGRAPHY received FDA 510(k) clearance on 2003-05-06, under 510(k) number K023943.

Who is the listed applicant for CT COLONOGRAPHY?

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?

The FDA product code for CT COLONOGRAPHY 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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