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FDA 510(k)

INFX-8000H, INFINIX-I

K-Number: K082830 · 2008-10-10

ApplicantToshiba America Medical Systems, In.C
Decision Date2008-10-10
Product CodeJAA
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

INFX-8000H, INFINIX-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 2008-10-10 under 510(k) number K082830. The device is classified under product code JAA. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFX-8000H, INFINIX-I?

INFX-8000H, INFINIX-I is a medical device that received FDA 510(k) clearance on 2008-10-10. The listed applicant is Toshiba America Medical Systems, In.C. The 510(k) number is K082830.

When did INFX-8000H, INFINIX-I receive FDA 510(k) clearance?

INFX-8000H, INFINIX-I received FDA 510(k) clearance on 2008-10-10, under 510(k) number K082830.

Who is the listed applicant for INFX-8000H, INFINIX-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 INFX-8000H, INFINIX-I?

The FDA product code for INFX-8000H, INFINIX-I is JAA.

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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: JAA)

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.

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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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