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FDA 510(k)

CT PROSPEED CT/I

K-Number: K961055 · 1996-06-17

ApplicantGE Medical Systems
Decision Date1996-06-17
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CT PROSPEED CT/I is the device name listed in this FDA 510(k) record. The listed applicant is GE Medical Systems. It received FDA 510(k) clearance on 1996-06-17 under 510(k) number K961055. 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 PROSPEED CT/I?

CT PROSPEED CT/I is a medical device that received FDA 510(k) clearance on 1996-06-17. The listed applicant is GE Medical Systems. The 510(k) number is K961055.

When did CT PROSPEED CT/I receive FDA 510(k) clearance?

CT PROSPEED CT/I received FDA 510(k) clearance on 1996-06-17, under 510(k) number K961055.

Who is the listed applicant for CT PROSPEED CT/I?

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

What is the FDA product code for CT PROSPEED CT/I?

The FDA product code for CT PROSPEED CT/I is JAK.

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Other records listing GE Medical Systems 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.

K253808AIR Recon DLK220851VenueK220848Venue FitK173341Vivid E80, Vivid E90, Vivid E95K103411IDEAL IQ SOFTWARE OPTIONK073138CARDIQ EXPRESS VERSION 2.0

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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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