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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 the device name listed in this FDA 510(k) record. The listed applicant is Hitachi Healthcare Americas. It received FDA 510(k) clearance on 2019-02-01 under 510(k) 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. The listed applicant is Hitachi Healthcare Americas. The 510(k) number is K183291.

When did Supria True64 Whole-Body X-Ray CT System receive FDA 510(k) clearance?

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

Who is the listed applicant for Supria True64 Whole-Body X-Ray CT System?

The FDA 510(k) record lists Hitachi Healthcare Americas as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Hitachi Healthcare Americas as applicant

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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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