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FDA 510(k), K100371, SPY INTRA-OPERATIVE IMAGING SYSTEM
FDA 510(k), K100371, SPY INTRA-OPERATIVE IMAGING SYSTEM
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510(K) Number: K100371
Device Name: SPY INTRA-OPERATIVE IMAGING SYSTEM
Manufacturer: NOVADAQ TECHNOLOGIES, INC.
Device Classification Name: system, x-ray, angiographic
Regulation Number: 892.1600
Classification Product Code: IZI
Date Received: 02/12/2010
Decision Date: 02/04/2011
Regulation Medical Specialty: Radiology
Device Name: SPY INTRA-OPERATIVE IMAGING SYSTEM
Manufacturer: NOVADAQ TECHNOLOGIES, INC.
Device Classification Name: system, x-ray, angiographic
Regulation Number: 892.1600
Classification Product Code: IZI
Date Received: 02/12/2010
Decision Date: 02/04/2011
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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