Syngo.Mr Onco, Syngo.Mr 3D Lesion Segmentation, Syngo.Mr Onco Engine
FDA 510(k) K111861 · Siemens Medical Systems USA
510(k) numberK111861
Submission
- Device name
- Syngo.Mr Onco, Syngo.Mr 3D Lesion Segmentation, Syngo.Mr Onco Engine
- Applicant
- Siemens Medical Systems USA
Malvern, PA, US - Received
- June 30, 2011
- Decision date
- January 6, 2012
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Syngo.Mr Onco, Syngo.Mr 3D Lesion Segmentation, Syngo.Mr Onco Engine cleared by the FDA?
Syngo.Mr Onco, Syngo.Mr 3D Lesion Segmentation, Syngo.Mr Onco Engine (K111861) received a 510(k) decision of Substantially Equivalent on January 6, 2012, 190 days after the submission was received.
What is the product code of K111861?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.