FDA 510(k)

TSX-201A, AQUILION LB CT SCANNER WITH RESPIRATORY GATING

K-Number: K061187 · 2006-05-12

ApplicantToshiba America Medical Systems, In.C

Decision Date2006-05-12

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

TSX-201A, AQUILION LB CT SCANNER WITH RESPIRATORY GATING 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 2006-05-12 under 510(k) number K061187. 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-201A, AQUILION LB CT SCANNER WITH RESPIRATORY GATING?

TSX-201A, AQUILION LB CT SCANNER WITH RESPIRATORY GATING is a medical device that received FDA 510(k) clearance on 2006-05-12. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K061187.

When did TSX-201A, AQUILION LB CT SCANNER WITH RESPIRATORY GATING receive FDA 510(k) clearance?

TSX-201A, AQUILION LB CT SCANNER WITH RESPIRATORY GATING received FDA 510(k) clearance on 2006-05-12, under 510(k) number K061187.

Who is the listed applicant for TSX-201A, AQUILION LB CT SCANNER WITH RESPIRATORY GATING?

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-201A, AQUILION LB CT SCANNER WITH RESPIRATORY GATING?

The FDA product code for TSX-201A, AQUILION LB CT SCANNER WITH RESPIRATORY GATING 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.