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FDA 510(k)

TSX-101A/H AQUILION 64 SP CT SCANNER; TSX-101A/I AQUILION 32 SP CT SCANNER

K-Number: K051833 · 2005-07-15

ApplicantToshiba America Medical Systems, In.C
Decision Date2005-07-15
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TSX-101A/H AQUILION 64 SP CT SCANNER; TSX-101A/I AQUILION 32 SP CT SCANNER 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 2005-07-15 under 510(k) number K051833. 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-101A/H AQUILION 64 SP CT SCANNER; TSX-101A/I AQUILION 32 SP CT SCANNER?

TSX-101A/H AQUILION 64 SP CT SCANNER; TSX-101A/I AQUILION 32 SP CT SCANNER is a medical device that received FDA 510(k) clearance on 2005-07-15. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K051833.

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

TSX-101A/H AQUILION 64 SP CT SCANNER; TSX-101A/I AQUILION 32 SP CT SCANNER received FDA 510(k) clearance on 2005-07-15, under 510(k) number K051833.

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

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-101A/H AQUILION 64 SP CT SCANNER; TSX-101A/I AQUILION 32 SP CT SCANNER?

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