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FDA 510(k)

INFX-8000F (INFINIX CSI AND INFINIX DPI)

K-Number: K081624 · 2008-06-23

ApplicantToshiba America Medical Systems, In.C
Decision Date2008-06-23
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INFX-8000F (INFINIX CSI AND INFINIX DPI) 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 2008-06-23 under 510(k) number K081624. 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 INFX-8000F (INFINIX CSI AND INFINIX DPI)?

INFX-8000F (INFINIX CSI AND INFINIX DPI) is a medical device that received FDA 510(k) clearance on 2008-06-23. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K081624.

When did INFX-8000F (INFINIX CSI AND INFINIX DPI) receive FDA 510(k) clearance?

INFX-8000F (INFINIX CSI AND INFINIX DPI) received FDA 510(k) clearance on 2008-06-23, under 510(k) number K081624.

Who is the listed applicant for INFX-8000F (INFINIX CSI AND INFINIX DPI)?

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 INFX-8000F (INFINIX CSI AND INFINIX DPI)?

The FDA product code for INFX-8000F (INFINIX CSI AND INFINIX DPI) 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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