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FDA 510(k)

SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO

K-Number: K121434 · 2012-11-05

ApplicantSiemens Medi Cal Solutions, Inc.
Decision Date2012-11-05
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medi Cal Solutions, Inc.. It received FDA 510(k) clearance on 2012-11-05 under 510(k) number K121434. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO?

SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO is a medical device that received FDA 510(k) clearance on 2012-11-05. The listed applicant is Siemens Medi Cal Solutions, Inc.. The 510(k) number is K121434.

When did SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO receive FDA 510(k) clearance?

SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO received FDA 510(k) clearance on 2012-11-05, under 510(k) number K121434.

Who is the listed applicant for SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO?

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

What is the FDA product code for SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO?

The FDA product code for SOFTWARE SYNGO MR D13A FOR THE MAGNETOM SYSTEMS AERA/SKYRA/AVANTO/VERIO is LNH.

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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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