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FDA 510(k)

MAMMOMAT INSPIRATION PRIME

K-Number: K123520 · 2013-06-11

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2013-06-11
Product CodeMUE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAMMOMAT INSPIRATION PRIME is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2013-06-11 under 510(k) number K123520. 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 MAMMOMAT INSPIRATION PRIME?

MAMMOMAT INSPIRATION PRIME is a medical device that received FDA 510(k) clearance on 2013-06-11. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K123520.

When did MAMMOMAT INSPIRATION PRIME receive FDA 510(k) clearance?

MAMMOMAT INSPIRATION PRIME received FDA 510(k) clearance on 2013-06-11, under 510(k) number K123520.

Who is the listed applicant for MAMMOMAT INSPIRATION PRIME?

The FDA 510(k) record lists Siemens Medical Solutions USA, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MAMMOMAT INSPIRATION PRIME?

The FDA product code for MAMMOMAT INSPIRATION PRIME is MUE.

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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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