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FDA 510(k)

CT SCANNER ND 8000

K-Number: K781040 · 1978-07-18

ApplicantCgr Medical Corp.
Decision Date1978-07-18
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CT SCANNER ND 8000 is the device name listed in this FDA 510(k) record. The listed applicant is Cgr Medical Corp.. It received FDA 510(k) clearance on 1978-07-18 under 510(k) number K781040. 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 SCANNER ND 8000?

CT SCANNER ND 8000 is a medical device that received FDA 510(k) clearance on 1978-07-18. The listed applicant is Cgr Medical Corp.. The 510(k) number is K781040.

When did CT SCANNER ND 8000 receive FDA 510(k) clearance?

CT SCANNER ND 8000 received FDA 510(k) clearance on 1978-07-18, under 510(k) number K781040.

Who is the listed applicant for CT SCANNER ND 8000?

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

What is the FDA product code for CT SCANNER ND 8000?

The FDA product code for CT SCANNER ND 8000 is JAK.

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Other records listing Cgr Medical Corp. 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.

K843926PRESTILIX 1690K843235STENOSCOPK843985SUSPENSION 7K841649MAXIMAX - 4K833223SONEL 3000AK833941ORION

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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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