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FDA 510(k)

HISPEED CT/I WITH PERFORMIX TUBE AND WARP SCAN OPTION

K-Number: K964746 · 1997-01-24

ApplicantGE Medical Systems
Decision Date1997-01-24
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HISPEED CT/I WITH PERFORMIX TUBE AND WARP SCAN OPTION 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 1997-01-24 under 510(k) number K964746. 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 HISPEED CT/I WITH PERFORMIX TUBE AND WARP SCAN OPTION?

HISPEED CT/I WITH PERFORMIX TUBE AND WARP SCAN OPTION is a medical device that received FDA 510(k) clearance on 1997-01-24. The listed applicant is GE Medical Systems. The 510(k) number is K964746.

When did HISPEED CT/I WITH PERFORMIX TUBE AND WARP SCAN OPTION receive FDA 510(k) clearance?

HISPEED CT/I WITH PERFORMIX TUBE AND WARP SCAN OPTION received FDA 510(k) clearance on 1997-01-24, under 510(k) number K964746.

Who is the listed applicant for HISPEED CT/I WITH PERFORMIX TUBE AND WARP SCAN OPTION?

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 HISPEED CT/I WITH PERFORMIX TUBE AND WARP SCAN OPTION?

The FDA product code for HISPEED CT/I WITH PERFORMIX TUBE AND WARP SCAN OPTION is JAK.

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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.

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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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