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FDA 510(k)

GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0)

K-Number: K081105 · 2008-05-09

ApplicantGE Healthcare
Decision Date2008-05-09
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0) is the device name listed in this FDA 510(k) record. The listed applicant is GE Healthcare. It received FDA 510(k) clearance on 2008-05-09 under 510(k) number K081105. 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 GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0)?

GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0) is a medical device that received FDA 510(k) clearance on 2008-05-09. The listed applicant is GE Healthcare. The 510(k) number is K081105.

When did GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0) receive FDA 510(k) clearance?

GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0) received FDA 510(k) clearance on 2008-05-09, under 510(k) number K081105.

Who is the listed applicant for GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0)?

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

What is the FDA product code for GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0)?

The FDA product code for GE LIGHTSPEED CT750 HD (LIGHTSPEED 8.0) is JAK.

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Other records listing GE Healthcare 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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