FDA 510(k)

HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA

K-Number: K052434 · 2005-09-27

Decision Date2005-09-27

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

HAWKEYE 4 OPTION 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. It received FDA 510(k) clearance on 2005-09-27 under 510(k) number K052434. 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 HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA?

HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA is a medical device that received FDA 510(k) clearance on 2005-09-27. The listed applicant is GE Medical Systems. The 510(k) number is K052434.

When did HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA receive FDA 510(k) clearance?

HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA received FDA 510(k) clearance on 2005-09-27, under 510(k) number K052434.

Who is the listed applicant for HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA?

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 HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA?

The FDA product code for HAWKEYE 4 OPTION FOR DUAL-HEAD VARIABLE ANGLE GAMMA CAMERA is KPS.

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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.