FDA 510(k)

VTRANSACT: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA

K-Number: K980959 · 1998-06-04

Decision Date1998-06-04

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

VTRANSACT: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems F.I. Haifa. It received FDA 510(k) clearance on 1998-06-04 under 510(k) number K980959. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VTRANSACT: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA?

VTRANSACT: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA is a medical device that received FDA 510(k) clearance on 1998-06-04. The listed applicant is Ge Medical Systems F.I. Haifa. The 510(k) number is K980959.

When did VTRANSACT: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA receive FDA 510(k) clearance?

VTRANSACT: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA received FDA 510(k) clearance on 1998-06-04, under 510(k) number K980959.

Who is the listed applicant for VTRANSACT: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA?

The FDA 510(k) record lists Ge Medical Systems F.I. Haifa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VTRANSACT: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA?

The FDA product code for VTRANSACT: ATTENUATION CORRECTION SYSTEM FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA is KPS.

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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.