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FDA 510(k)

CT 9000

K-Number: K843927 · 1984-12-17

ApplicantGeneral Electric Co.
Decision Date1984-12-17
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CT 9000 is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Co.. It received FDA 510(k) clearance on 1984-12-17 under 510(k) number K843927. 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 9000?

CT 9000 is a medical device that received FDA 510(k) clearance on 1984-12-17. The listed applicant is General Electric Co.. The 510(k) number is K843927.

When did CT 9000 receive FDA 510(k) clearance?

CT 9000 received FDA 510(k) clearance on 1984-12-17, under 510(k) number K843927.

Who is the listed applicant for CT 9000?

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

What is the FDA product code for CT 9000?

The FDA product code for CT 9000 is JAK.

Other records listing General Electric Co. 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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