FDA 510(k)

AUKLET CT SCANNER, TSX-003A

K-Number: K973908 · 1997-12-22

ApplicantToshiba America Medical Systems, In.C

Decision Date1997-12-22

Product CodeJAK

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

AUKLET CT SCANNER, TSX-003A 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 1997-12-22 under 510(k) number K973908. 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 AUKLET CT SCANNER, TSX-003A?

AUKLET CT SCANNER, TSX-003A is a medical device that received FDA 510(k) clearance on 1997-12-22. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K973908.

When did AUKLET CT SCANNER, TSX-003A receive FDA 510(k) clearance?

AUKLET CT SCANNER, TSX-003A received FDA 510(k) clearance on 1997-12-22, under 510(k) number K973908.

Who is the listed applicant for AUKLET CT SCANNER, TSX-003A?

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 AUKLET CT SCANNER, TSX-003A?

The FDA product code for AUKLET CT SCANNER, TSX-003A 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.