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FDA 510(k)

MAMMOREPORT SOFTCOPY WORKSTATION

K-Number: K042868 · 2005-01-06

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2005-01-06
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

MAMMOREPORT SOFTCOPY WORKSTATION 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 2005-01-06 under 510(k) number K042868. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAMMOREPORT SOFTCOPY WORKSTATION?

MAMMOREPORT SOFTCOPY WORKSTATION is a medical device that received FDA 510(k) clearance on 2005-01-06. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K042868.

When did MAMMOREPORT SOFTCOPY WORKSTATION receive FDA 510(k) clearance?

MAMMOREPORT SOFTCOPY WORKSTATION received FDA 510(k) clearance on 2005-01-06, under 510(k) number K042868.

Who is the listed applicant for MAMMOREPORT SOFTCOPY WORKSTATION?

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 MAMMOREPORT SOFTCOPY WORKSTATION?

The FDA product code for MAMMOREPORT SOFTCOPY WORKSTATION is LLZ.

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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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