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FDA 510(k)

FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB

K-Number: K110202 · 2011-02-08

ApplicantFujifilm Medical System U.S.A., Inc.
Decision Date2011-02-08
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Medical System U.S.A., Inc.. It received FDA 510(k) clearance on 2011-02-08 under 510(k) number K110202. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB?

FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB is a medical device that received FDA 510(k) clearance on 2011-02-08. The listed applicant is Fujifilm Medical System U.S.A., Inc.. The 510(k) number is K110202.

When did FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB receive FDA 510(k) clearance?

FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB received FDA 510(k) clearance on 2011-02-08, under 510(k) number K110202.

Who is the listed applicant for FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB?

The FDA 510(k) record lists Fujifilm Medical System U.S.A., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB?

The FDA product code for FUJIFILM DIAGNOSTIC ULTRASOUND SYSTEM FAZONE CB is ITX.

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Other records listing Fujifilm Medical System U.S.A., Inc. as applicant

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Related Devices (Code: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, 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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