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FDA 510(k), K140666, MR ELASTOGRAPHY
FDA 510(k), K140666, MR ELASTOGRAPHY
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510(K) Number: K140666
Device Name: MR ELASTOGRAPHY
Manufacturer: SUSAN QUICK
Device Classification Name: System, Nuclear Magnetic Resonance Imaging
Regulation Number: LNH
Classification Product Code: KXA
Date Received: 03/18/2014
Decision Date: 06/13/2014
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: MR ELASTOGRAPHY
Manufacturer: SUSAN QUICK
Device Classification Name: System, Nuclear Magnetic Resonance Imaging
Regulation Number: LNH
Classification Product Code: KXA
Date Received: 03/18/2014
Decision Date: 06/13/2014
Decision: Substantially Equivalent (SESE)
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. Learn more about Fast-Track Requests here.
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