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FDA 510(k), K163234, Biograph mMR with syngo MR E11P system software
FDA 510(k), K163234, Biograph mMR with syngo MR E11P system software
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510(K) Number: K163234
Device Name: Biograph mMR with syngo MR E11P system software
Manufacturer: Siemens Medical Solutions USA, Inc.
Device Classification Name: tomographic imager combining emission computed tomography with nuclear magnetic resonance
Regulation Number: 892.1200
Classification Product Code: OUO
Date Received: 11/17/2016
Decision Date: 02/28/2017
Regulation Medical Specialty: Radiology
Device Name: Biograph mMR with syngo MR E11P system software
Manufacturer: Siemens Medical Solutions USA, Inc.
Device Classification Name: tomographic imager combining emission computed tomography with nuclear magnetic resonance
Regulation Number: 892.1200
Classification Product Code: OUO
Date Received: 11/17/2016
Decision Date: 02/28/2017
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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