FDA 510(k)

SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800 SERIES

K-Number: K994431 · 2000-03-23

Decision Date2000-03-23

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800 SERIES 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 2000-03-23 under 510(k) number K994431. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800 SERIES?

SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800 SERIES is a medical device that received FDA 510(k) clearance on 2000-03-23. The listed applicant is Shimadzu Medical Systems. The 510(k) number is K994431.

When did SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800 SERIES receive FDA 510(k) clearance?

SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800 SERIES received FDA 510(k) clearance on 2000-03-23, under 510(k) number K994431.

Who is the listed applicant for SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800 SERIES?

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 SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800 SERIES?

The FDA product code for SHIMADZU WHOLE BODY X-RAY COMPUTED TOMOGRAPHY SCANNER SCT-7800 SERIES is JAK.

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Related Devices (Code: JAK)

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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.