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FDA 510(k), K160618, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T
FDA 510(k), K160618, Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T
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510(K) Number: K160618
Device Name: Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T
Manufacturer: GE MEDICAL SYSTEMS, LLC
Device Classification Name: system, nuclear magnetic resonance imaging
Regulation Number: 892.1000
Classification Product Code: LNH
Date Received: 03/03/2016
Decision Date: 06/09/2016
Regulation Medical Specialty: Radiology
Device Name: Discovery MR750 3.0T, Discovery MR450 1.5T, Discovery MR750w 3.0T, Optima MR450w 1.5T
Manufacturer: GE MEDICAL SYSTEMS, LLC
Device Classification Name: system, nuclear magnetic resonance imaging
Regulation Number: 892.1000
Classification Product Code: LNH
Date Received: 03/03/2016
Decision Date: 06/09/2016
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. IMPORTANT: The FDA FOIA office operations are currently suspended. We are happy to make the request but do not know when we will receive a response. Learn more about Fast-Track Requests here.
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