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FDA 510(k)

ASPIRE HD PLUS, ASPIRE HD-S

K-Number: K121674 · 2012-09-21

ApplicantFujifilm Medical System U.S.A., Inc.
Decision Date2012-09-21
Product CodeMUE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

ASPIRE HD PLUS, ASPIRE HD-S 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 2012-09-21 under 510(k) number K121674. 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 PLUS, ASPIRE HD-S?

ASPIRE HD PLUS, ASPIRE HD-S is a medical device that received FDA 510(k) clearance on 2012-09-21. The listed applicant is Fujifilm Medical System U.S.A., Inc.. The 510(k) number is K121674.

When did ASPIRE HD PLUS, ASPIRE HD-S receive FDA 510(k) clearance?

ASPIRE HD PLUS, ASPIRE HD-S received FDA 510(k) clearance on 2012-09-21, under 510(k) number K121674.

Who is the listed applicant for ASPIRE HD PLUS, ASPIRE HD-S?

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 ASPIRE HD PLUS, ASPIRE HD-S?

The FDA product code for ASPIRE HD PLUS, ASPIRE HD-S is MUE.

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

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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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