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FDA 510(k)

DRAD30003/RADREX-I

K-Number: K083503 · 2009-02-13

ApplicantToshiba America Medical Systems, In.C
Decision Date2009-02-13
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DRAD30003/RADREX-I 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 2009-02-13 under 510(k) number K083503. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRAD30003/RADREX-I?

DRAD30003/RADREX-I is a medical device that received FDA 510(k) clearance on 2009-02-13. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K083503.

When did DRAD30003/RADREX-I receive FDA 510(k) clearance?

DRAD30003/RADREX-I received FDA 510(k) clearance on 2009-02-13, under 510(k) number K083503.

Who is the listed applicant for DRAD30003/RADREX-I?

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 DRAD30003/RADREX-I?

The FDA product code for DRAD30003/RADREX-I is KPR.

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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: KPR)

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.

K260227EXSYS DEXi (EXSYS DEXi-S40S); EXSYS DEXi (EXSYS DEXi-S40P); EXSYS DEXi (EXSYS DEXi-S40T); EXSYS DEXi (EXSYS DEXi-S50HDRTECH CorporationK260488MULTIX Impact; MULTIX Impact CSiemens Medical Solutions USA, Inc.K260481GC85ASamsung Electronics Co., Ltd.K260482DRE DuoJpi Healthcare Co, Ltd.K253446AeroDR TX c02Dk Medical Systems Co., Ltd.K250954DRX-Evolution Plus X-ray System, DRX-Compass Mobile X-ray System, Lux HD 35 detector, Lux HD 43 detectorCarestream Health

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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