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FDA 510(k)

TF-63SA

K-Number: K904044 · 1990-11-29

ApplicantToshiba America Medical Systems, In.C
Decision Date1990-11-29
Product CodeKPW
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

TF-63SA 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 1990-11-29 under 510(k) number K904044. The device is classified under product code KPW. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TF-63SA?

TF-63SA is a medical device that received FDA 510(k) clearance on 1990-11-29. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K904044.

When did TF-63SA receive FDA 510(k) clearance?

TF-63SA received FDA 510(k) clearance on 1990-11-29, under 510(k) number K904044.

Who is the listed applicant for TF-63SA?

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 TF-63SA?

The FDA product code for TF-63SA is KPW.

Other records listing Toshiba America Medical Systems, In.C as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K132106INFINIX ANGIO WORKSTATION W/DTS SOFTWAREK131822ULTRAEXTEND USWS-900A V2.1 AND V3.1K123097DOSE TRACKING SYSTEM MODEL XIDF-DTS801K122613VANTAGE TITAN WITH HELIOS GRADIENT MODEL MRT-1504/USK121076ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGEK122842RADREX-I, SW V4.00 MODEL DRAD-3000E

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Related Devices (Code: KPW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K093596LUMOS, MODEL R 72BLumos, Inc.K062788COLLIMATOR, MODEL M-38Umi InternationalK030487R 72Ralco S.R.L.K954310BLA-800AToshiba Medical SystemsK946320R 302Ralco S.R.L.K914184P2020-8-0 BEAM-LIMITING DEVICEPrecise Optics

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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