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FDA 510(k)

OMNI SCANNER CT 6000

K-Number: K802206 · 1980-10-23

ApplicantOmnimedical
Decision Date1980-10-23
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

OMNI SCANNER CT 6000 is the device name listed in this FDA 510(k) record. The listed applicant is Omnimedical. It received FDA 510(k) clearance on 1980-10-23 under 510(k) number K802206. 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 OMNI SCANNER CT 6000?

OMNI SCANNER CT 6000 is a medical device that received FDA 510(k) clearance on 1980-10-23. The listed applicant is Omnimedical. The 510(k) number is K802206.

When did OMNI SCANNER CT 6000 receive FDA 510(k) clearance?

OMNI SCANNER CT 6000 received FDA 510(k) clearance on 1980-10-23, under 510(k) number K802206.

Who is the listed applicant for OMNI SCANNER CT 6000?

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

What is the FDA product code for OMNI SCANNER CT 6000?

The FDA product code for OMNI SCANNER CT 6000 is JAK.

Related Clinical Trials

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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Other records listing Omnimedical 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.

K837378OMNIMEDICAL QUAD II DIGITAL ANGIOGRAPH SYSTEMK820180CALCULI FILTER CUPK8123934001 CT SCANNERK812400OMNIMEDICAL QUAD IK790673OMNIMEDICAL AUTOMATIC 1001

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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