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FDA 510(k)

TSX-301A, AQUILION ONE CT SYSTEM

K-Number: K063189 · 2006-11-03

ApplicantToshiba America Medical Systems, In.C
Decision Date2006-11-03
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TSX-301A, AQUILION ONE CT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Toshiba America Medical Systems, In.C. It received FDA 510(k) clearance on 2006-11-03 under 510(k) number K063189. 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 TSX-301A, AQUILION ONE CT SYSTEM?

TSX-301A, AQUILION ONE CT SYSTEM is a medical device that received FDA 510(k) clearance on 2006-11-03. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K063189.

When did TSX-301A, AQUILION ONE CT SYSTEM receive FDA 510(k) clearance?

TSX-301A, AQUILION ONE CT SYSTEM received FDA 510(k) clearance on 2006-11-03, under 510(k) number K063189.

Who is the listed applicant for TSX-301A, AQUILION ONE CT SYSTEM?

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

What is the FDA product code for TSX-301A, AQUILION ONE CT SYSTEM?

The FDA product code for TSX-301A, AQUILION ONE 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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