FDA 510(k)

HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMS

K-Number: K954143 · 1995-12-22

ApplicantHitachi Medical Corp. of America

Decision Date1995-12-22

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMS is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Medical Corp. of America. It received FDA 510(k) clearance on 1995-12-22 under 510(k) number K954143. 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 HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMS?

HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMS is a medical device that received FDA 510(k) clearance on 1995-12-22. The listed applicant is Hitachi Medical Corp. of America. The 510(k) number is K954143.

When did HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMS receive FDA 510(k) clearance?

HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMS received FDA 510(k) clearance on 1995-12-22, under 510(k) number K954143.

Who is the listed applicant for HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMS?

The FDA 510(k) record lists Hitachi Medical Corp. of America as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMS?

The FDA product code for HITACHI SPECTRADIGITAL SERIES GAMMA CAMERA SYSTEMS is KPS.

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Other records listing Hitachi Medical Corp. of America as applicant

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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.