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FDA 510(k), K092639, INNOVA VISION, MODEL S18751VN, INNOVA TRACKVISION, MODEL S18751VT, INNOVA EPVISION, MODEL S18751EP
FDA 510(k), K092639, INNOVA VISION, MODEL S18751VN, INNOVA TRACKVISION, MODEL S18751VT, INNOVA EPVISION, MODEL S18751EP
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510(K) Number: K092639
Device Name: INNOVA VISION, MODEL S18751VN, INNOVA TRACKVISION, MODEL S18751VT, INNOVA EPVISION, MODEL S18751EP
Manufacturer: GE MEDICAL SYSTEMS SCS
Device Classification Name: system, image processing, radiological
Regulation Number: 892.2050
Classification Product Code: LLZ
Date Received: 08/27/2009
Decision Date: 12/02/2009
Regulation Medical Specialty: Radiology
Device Name: INNOVA VISION, MODEL S18751VN, INNOVA TRACKVISION, MODEL S18751VT, INNOVA EPVISION, MODEL S18751EP
Manufacturer: GE MEDICAL SYSTEMS SCS
Device Classification Name: system, image processing, radiological
Regulation Number: 892.2050
Classification Product Code: LLZ
Date Received: 08/27/2009
Decision Date: 12/02/2009
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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