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FDA 510(k)

SYNGO.MR ONCO, SYNGO.MR 3D LESION SEGMENTATION, SYNGO.MR ONCO ENGINE

K-Number: K111861 · 2012-01-06

ApplicantSiemens Medical Systems USA
Decision Date2012-01-06
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SYNGO.MR ONCO, SYNGO.MR 3D LESION SEGMENTATION, SYNGO.MR ONCO ENGINE is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Systems USA. It received FDA 510(k) clearance on 2012-01-06 under 510(k) number K111861. 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.MR ONCO, SYNGO.MR 3D LESION SEGMENTATION, SYNGO.MR ONCO ENGINE?

SYNGO.MR ONCO, SYNGO.MR 3D LESION SEGMENTATION, SYNGO.MR ONCO ENGINE is a medical device that received FDA 510(k) clearance on 2012-01-06. The listed applicant is Siemens Medical Systems USA. The 510(k) number is K111861.

When did SYNGO.MR ONCO, SYNGO.MR 3D LESION SEGMENTATION, SYNGO.MR ONCO ENGINE receive FDA 510(k) clearance?

SYNGO.MR ONCO, SYNGO.MR 3D LESION SEGMENTATION, SYNGO.MR ONCO ENGINE received FDA 510(k) clearance on 2012-01-06, under 510(k) number K111861.

Who is the listed applicant for SYNGO.MR ONCO, SYNGO.MR 3D LESION SEGMENTATION, SYNGO.MR ONCO ENGINE?

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

What is the FDA product code for SYNGO.MR ONCO, SYNGO.MR 3D LESION SEGMENTATION, SYNGO.MR ONCO ENGINE?

The FDA product code for SYNGO.MR ONCO, SYNGO.MR 3D LESION SEGMENTATION, SYNGO.MR ONCO ENGINE 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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