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FDA 510(k), K122429, VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUAL
FDA 510(k), K122429, VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUAL
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510(K) Number: K122429
Device Name: VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUAL
Manufacturer: OBJECT RESEARCH SYSTEMS (ORS) INC.
Device Classification Name: system, image processing, radiological
Regulation Number: 892.2050
Classification Product Code: LLZ
Date Received: 08/09/2012
Decision Date: 11/28/2012
Regulation Medical Specialty: Radiology
Device Name: VESSEL ANALYSIS AND AUTOPLAQUE FOR ORS VISUAL
Manufacturer: OBJECT RESEARCH SYSTEMS (ORS) INC.
Device Classification Name: system, image processing, radiological
Regulation Number: 892.2050
Classification Product Code: LLZ
Date Received: 08/09/2012
Decision Date: 11/28/2012
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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