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FDA 510(k)

ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM

K-Number: K110729 · 2011-09-01

ApplicantFujifilm Medical Systems U.S.A, Inc.
Decision Date2011-09-01
Product CodeMUE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. It received FDA 510(k) clearance on 2011-09-01 under 510(k) number K110729. The device is classified under product code MUE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM?

ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM is a medical device that received FDA 510(k) clearance on 2011-09-01. The listed applicant is Fujifilm Medical Systems U.S.A, Inc.. The 510(k) number is K110729.

When did ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM receive FDA 510(k) clearance?

ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM received FDA 510(k) clearance on 2011-09-01, under 510(k) number K110729.

Who is the listed applicant for ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM?

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

What is the FDA product code for ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM?

The FDA product code for ASPIRE HD FULL-FIELD DIGITAL MAMMOGRAPHY SYSTEM is MUE.

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

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Related Devices (Code: MUE)

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.

K254090I-View®Hologic, Inc.K253678MAMMOMAT B.brilliant (11372950)Siemens Medical Solutions USA, Inc.K254092Bellalun 2D (VDMS-1000S)Vieworks Co., Ltd.K260087Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena BrightGE Medical Systems SCSK243420HESTIAGenoray Co., Ltd.K2438492430TCA with Xmaru WRayence Co., Ltd.

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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