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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 a medical device manufactured by Hitachi Medical Systems America, Inc.. It received FDA 510(k) clearance on 2017-03-03 under approval 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. It is manufactured by Hitachi Medical Systems America, Inc.. The 510(k) number is K163528.

When was HITACHI Supria Whole-body X-ray CT System Phase 3 approved by the FDA?

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

What company makes HITACHI Supria Whole-body X-ray CT System Phase 3?

HITACHI Supria Whole-body X-ray CT System Phase 3 is manufactured by Hitachi Medical Systems America, Inc..

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.

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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.

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