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FDA 510(k), K052698, MODIFICATION TO: AURORA
FDA 510(k), K052698, MODIFICATION TO: AURORA
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510(K) Number: K052698
Device Name: MODIFICATION TO: AURORA
Manufacturer: AURORA IMAGING TECHNOLOGY, INC.
Device Classification Name: system, nuclear magnetic resonance imaging
Regulation Number: 892.1000
Classification Product Code: LNH
Date Received: 09/28/2005
Decision Date: 11/08/2005
Regulation Medical Specialty: Radiology
Device Name: MODIFICATION TO: AURORA
Manufacturer: AURORA IMAGING TECHNOLOGY, INC.
Device Classification Name: system, nuclear magnetic resonance imaging
Regulation Number: 892.1000
Classification Product Code: LNH
Date Received: 09/28/2005
Decision Date: 11/08/2005
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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