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FDA 510(k)

DUA-900A IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYST

K-Number: K922364 · 1992-09-04

ApplicantToshiba America Medical Systems, In.C
Decision Date1992-09-04
Product CodeIXR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DUA-900A IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYST 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 1992-09-04 under 510(k) number K922364. The device is classified under product code IXR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUA-900A IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYST?

DUA-900A IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYST is a medical device that received FDA 510(k) clearance on 1992-09-04. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K922364.

When did DUA-900A IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYST receive FDA 510(k) clearance?

DUA-900A IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYST received FDA 510(k) clearance on 1992-09-04, under 510(k) number K922364.

Who is the listed applicant for DUA-900A IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYST?

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 DUA-900A IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYST?

The FDA product code for DUA-900A IMAGE-INTENSIFIED FLUOROSCOPIC X-RAY SYST is IXR.

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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: IXR)

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.

K000412VISION R/F TILTING TABLEVilla Sistemi Medicali S.P.A.K973039LEGACY/LEGACY-D TABLEGE Medical SystemsK971128CAP-35B III/CINE 275Jamieson Film Co.K970640PHILIPS EASY DIAGNOSTPhilips Medical Systems North America, Inc.K965105ELECTROPHYSIOLOGY TILT TABLE MODEL #9660U.S. Imaging Tables, Inc.K965096FLUOROVIEW SERIES FLUOROSCOPIC TABLESU.S. Imaging Tables, Inc.

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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