FDA 510(k)

ASPECT GAMMA CAMERA

K-Number: K896458 · 1989-12-22

Decision Date1989-12-22

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

ASPECT GAMMA CAMERA is the device name listed in this FDA 510(k) record. The listed applicant is Digital Scintigraphics, Inc.. It received FDA 510(k) clearance on 1989-12-22 under 510(k) number K896458. 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 ASPECT GAMMA CAMERA?

ASPECT GAMMA CAMERA is a medical device that received FDA 510(k) clearance on 1989-12-22. The listed applicant is Digital Scintigraphics, Inc.. The 510(k) number is K896458.

When did ASPECT GAMMA CAMERA receive FDA 510(k) clearance?

ASPECT GAMMA CAMERA received FDA 510(k) clearance on 1989-12-22, under 510(k) number K896458.

Who is the listed applicant for ASPECT GAMMA CAMERA?

The FDA 510(k) record lists Digital Scintigraphics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ASPECT GAMMA CAMERA?

The FDA product code for ASPECT 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.