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FDA 510(k), K110151, ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T
FDA 510(k), K110151, ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T
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510(K) Number: K110151
Device Name: ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T
Manufacturer: LYNN HARMER
Device Classification Name: System, Nuclear Magnetic Resonance Imaging
Regulation Number: LNH
Classification Product Code: 01/18/2011
Date Received: 03/22/2011
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: ACHIEVA R4 1.5T AND ACHIEVA R4 3.0T
Manufacturer: LYNN HARMER
Device Classification Name: System, Nuclear Magnetic Resonance Imaging
Regulation Number: LNH
Classification Product Code: 01/18/2011
Date Received: 03/22/2011
Decision Date: Substantially Equivalent (SESE)
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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