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FDA 510(k)

Supria True64 Whole-Body X-Ray CT System

K-Number: K183291 · 2019-02-01

ApplicantHitachi Healthcare Americas
Decision Date2019-02-01
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Supria True64 Whole-Body X-Ray CT System is a medical device manufactured by Hitachi Healthcare Americas. It received FDA 510(k) clearance on 2019-02-01 under approval number K183291. 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 Supria True64 Whole-Body X-Ray CT System?

Supria True64 Whole-Body X-Ray CT System is a medical device that received FDA 510(k) clearance on 2019-02-01. It is manufactured by Hitachi Healthcare Americas. The 510(k) number is K183291.

When was Supria True64 Whole-Body X-Ray CT System approved by the FDA?

Supria True64 Whole-Body X-Ray CT System received FDA 510(k) clearance on 2019-02-01, under approval number K183291.

What company makes Supria True64 Whole-Body X-Ray CT System?

Supria True64 Whole-Body X-Ray CT System is manufactured by Hitachi Healthcare Americas.

What is the FDA product code for Supria True64 Whole-Body X-Ray CT System?

The FDA product code for Supria True64 Whole-Body X-Ray CT System 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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