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FDA 510(k)

INFINIX-CCI

K-Number: K113052 · 2011-11-22

ApplicantToshiba America Medical Systems, In.C
Decision Date2011-11-22
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INFINIX-CCI 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 2011-11-22 under 510(k) number K113052. 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 INFINIX-CCI?

INFINIX-CCI is a medical device that received FDA 510(k) clearance on 2011-11-22. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K113052.

When did INFINIX-CCI receive FDA 510(k) clearance?

INFINIX-CCI received FDA 510(k) clearance on 2011-11-22, under 510(k) number K113052.

Who is the listed applicant for INFINIX-CCI?

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 INFINIX-CCI?

The FDA product code for INFINIX-CCI 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/USK122842RADREX-I, SW V4.00 MODEL DRAD-3000EK121076ULTRAEXTEND FX, ULTRASOUND WORKSTATION PACKAGE

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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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