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FDA 510(k)

SYNGO, BREAST CARE

K-Number: K123420 · 2013-02-01

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2013-02-01
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SYNGO, BREAST CARE 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 2013-02-01 under 510(k) number K123420. 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 SYNGO, BREAST CARE?

SYNGO, BREAST CARE is a medical device that received FDA 510(k) clearance on 2013-02-01. The listed applicant is Siemens Medical Solutions USA, Inc.. The 510(k) number is K123420.

When did SYNGO, BREAST CARE receive FDA 510(k) clearance?

SYNGO, BREAST CARE received FDA 510(k) clearance on 2013-02-01, under 510(k) number K123420.

Who is the listed applicant for SYNGO, BREAST CARE?

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 SYNGO, BREAST CARE?

The FDA product code for SYNGO, BREAST CARE 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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