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FDA 510(k), K190461, Achieva 1.5T, 3.0T and Intera 1.5T MR Systems
FDA 510(k), K190461, Achieva 1.5T, 3.0T and Intera 1.5T MR Systems
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510(K) Number: K190461
Device Name: Achieva 1.5T, 3.0T and Intera 1.5T MR Systems
Manufacturer: Jan van de Kerkhof
Device Classification Name: System, Nuclear Magnetic Resonance Imaging
Regulation Number: LNH
Classification Product Code: 02/26/2019
Date Received: 06/04/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: Achieva 1.5T, 3.0T and Intera 1.5T MR Systems
Manufacturer: Jan van de Kerkhof
Device Classification Name: System, Nuclear Magnetic Resonance Imaging
Regulation Number: LNH
Classification Product Code: 02/26/2019
Date Received: 06/04/2019
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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