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FDA 510(k)

HISPEED QX/I CT SCANNER SYSTEM

K-Number: K980176 · 1998-04-13

ApplicantGeneral Electric Co.
Decision Date1998-04-13
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HISPEED QX/I CT SCANNER SYSTEM 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 1998-04-13 under 510(k) number K980176. 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 QX/I CT SCANNER SYSTEM?

HISPEED QX/I CT SCANNER SYSTEM is a medical device that received FDA 510(k) clearance on 1998-04-13. The listed applicant is General Electric Co.. The 510(k) number is K980176.

When did HISPEED QX/I CT SCANNER SYSTEM receive FDA 510(k) clearance?

HISPEED QX/I CT SCANNER SYSTEM received FDA 510(k) clearance on 1998-04-13, under 510(k) number K980176.

Who is the listed applicant for HISPEED QX/I CT SCANNER SYSTEM?

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 HISPEED QX/I CT SCANNER SYSTEM?

The FDA product code for HISPEED QX/I CT SCANNER SYSTEM is JAK.

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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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