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FDA 510(k)

TSX-101A/A AND TSX-101A/C AQUILION MULTISLICE CT SCANNERS

K-Number: K033418 · 2003-11-10

ApplicantToshiba America Medical Systems, In.C
Decision Date2003-11-10
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TSX-101A/A AND TSX-101A/C AQUILION MULTISLICE CT SCANNERS 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 2003-11-10 under 510(k) number K033418. 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/A AND TSX-101A/C AQUILION MULTISLICE CT SCANNERS?

TSX-101A/A AND TSX-101A/C AQUILION MULTISLICE CT SCANNERS is a medical device that received FDA 510(k) clearance on 2003-11-10. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K033418.

When did TSX-101A/A AND TSX-101A/C AQUILION MULTISLICE CT SCANNERS receive FDA 510(k) clearance?

TSX-101A/A AND TSX-101A/C AQUILION MULTISLICE CT SCANNERS received FDA 510(k) clearance on 2003-11-10, under 510(k) number K033418.

Who is the listed applicant for TSX-101A/A AND TSX-101A/C AQUILION MULTISLICE CT SCANNERS?

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/A AND TSX-101A/C AQUILION MULTISLICE CT SCANNERS?

The FDA product code for TSX-101A/A AND TSX-101A/C AQUILION MULTISLICE CT SCANNERS 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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