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FDA 510(k)

MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM

K-Number: K080211 · 2008-03-14

ApplicantToshiba America Medical Systems, In.C
Decision Date2008-03-14
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MODEL TSX-101A/H/I AQUILION 32/64 SP 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 2008-03-14 under 510(k) number K080211. 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 MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM?

MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM is a medical device that received FDA 510(k) clearance on 2008-03-14. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K080211.

When did MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM receive FDA 510(k) clearance?

MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM received FDA 510(k) clearance on 2008-03-14, under 510(k) number K080211.

Who is the listed applicant for MODEL TSX-101A/H/I AQUILION 32/64 SP 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 MODEL TSX-101A/H/I AQUILION 32/64 SP CT SYSTEM?

The FDA product code for MODEL TSX-101A/H/I AQUILION 32/64 SP 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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