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FDA 510(k)

HITACHI Supria Whole-body X-ray CT System Phase 3

K-Number: K163528 · 2017-03-03

ApplicantHitachi Medical Systems America, Inc.
Decision Date2017-03-03
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

HITACHI Supria Whole-body X-ray CT System Phase 3 is the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Medical Systems America, Inc.. It received FDA 510(k) clearance on 2017-03-03 under 510(k) number K163528. 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 HITACHI Supria Whole-body X-ray CT System Phase 3?

HITACHI Supria Whole-body X-ray CT System Phase 3 is a medical device that received FDA 510(k) clearance on 2017-03-03. The listed applicant is Hitachi Medical Systems America, Inc.. The 510(k) number is K163528.

When did HITACHI Supria Whole-body X-ray CT System Phase 3 receive FDA 510(k) clearance?

HITACHI Supria Whole-body X-ray CT System Phase 3 received FDA 510(k) clearance on 2017-03-03, under 510(k) number K163528.

Who is the listed applicant for HITACHI Supria Whole-body X-ray CT System Phase 3?

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

What is the FDA product code for HITACHI Supria Whole-body X-ray CT System Phase 3?

The FDA product code for HITACHI Supria Whole-body X-ray CT System Phase 3 is JAK.

Other records listing Hitachi Medical Systems America, Inc. as applicant

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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.

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