FDA 510(k)

POSITRON EMISSION COMPUTED TOMOGRAPH SET-1400W

K-Number: K894056 · 1989-11-15

Decision Date1989-11-15

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

POSITRON EMISSION COMPUTED TOMOGRAPH SET-1400W is the device name listed in this FDA 510(k) record. The listed applicant is Shimadzu Medical Systems. It received FDA 510(k) clearance on 1989-11-15 under 510(k) number K894056. 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 POSITRON EMISSION COMPUTED TOMOGRAPH SET-1400W?

POSITRON EMISSION COMPUTED TOMOGRAPH SET-1400W is a medical device that received FDA 510(k) clearance on 1989-11-15. The listed applicant is Shimadzu Medical Systems. The 510(k) number is K894056.

When did POSITRON EMISSION COMPUTED TOMOGRAPH SET-1400W receive FDA 510(k) clearance?

POSITRON EMISSION COMPUTED TOMOGRAPH SET-1400W received FDA 510(k) clearance on 1989-11-15, under 510(k) number K894056.

Who is the listed applicant for POSITRON EMISSION COMPUTED TOMOGRAPH SET-1400W?

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

What is the FDA product code for POSITRON EMISSION COMPUTED TOMOGRAPH SET-1400W?

The FDA product code for POSITRON EMISSION COMPUTED TOMOGRAPH SET-1400W 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.