FDA 510(k)

AQUILION CT SCANNER, MODEL TSX-101A

K-Number: K982265 · 1998-08-26

ApplicantToshiba America Medical Systems, In.C

Decision Date1998-08-26

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

AQUILION CT SCANNER, MODEL TSX-101A 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 1998-08-26 under 510(k) number K982265. 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 AQUILION CT SCANNER, MODEL TSX-101A?

AQUILION CT SCANNER, MODEL TSX-101A is a medical device that received FDA 510(k) clearance on 1998-08-26. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K982265.

When did AQUILION CT SCANNER, MODEL TSX-101A receive FDA 510(k) clearance?

AQUILION CT SCANNER, MODEL TSX-101A received FDA 510(k) clearance on 1998-08-26, under 510(k) number K982265.

Who is the listed applicant for AQUILION CT SCANNER, MODEL TSX-101A?

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 AQUILION CT SCANNER, MODEL TSX-101A?

The FDA product code for AQUILION CT SCANNER, MODEL TSX-101A 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.