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FDA 510(k)

DRAD3000E/RADREX-I

K-Number: K082494 · 2008-09-12

ApplicantToshiba America Medical Systems, In.C
Decision Date2008-09-12
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DRAD3000E/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 2008-09-12 under 510(k) number K082494. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DRAD3000E/RADREX-I?

DRAD3000E/RADREX-I is a medical device that received FDA 510(k) clearance on 2008-09-12. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K082494.

When did DRAD3000E/RADREX-I receive FDA 510(k) clearance?

DRAD3000E/RADREX-I received FDA 510(k) clearance on 2008-09-12, under 510(k) number K082494.

Who is the listed applicant for DRAD3000E/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 DRAD3000E/RADREX-I?

The FDA product code for DRAD3000E/RADREX-I is MQB.

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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: MQB)

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.

K2538000909FCE, 0909FCE-HSRayence Co., Ltd.K260820VIVIX-S 4386W (FXRD-4386WA)Vieworks Co., Ltd.K252996Universal 1417PIKonica Minolta Healthcare Americas, Inc.K252911Lux HD 2530 detector (Lux HD 2530)Iray Imaging Technology (Haining) LimitedK250211Yushan X-Ray Flat Panel DetectorInnocare Optoelectronics Corp.K250665SKR 3000Konica Minolta, 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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