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FDA 510(k), K051967, REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS
FDA 510(k), K051967, REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS
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510(K) Number: K051967
Device Name: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS
Manufacturer: GE HEALTHCARE
Device Classification Name: system, x-ray, stationary
Regulation Number: 892.1680
Classification Product Code: KPR
Date Received: 07/20/2005
Decision Date: 08/09/2005
Regulation Medical Specialty: Radiology
Device Name: REVOLUTION XR/D DIGITAL RADIOGRAPHIC IMAGING SYSTEM WITH TOMOSYNTHESIS
Manufacturer: GE HEALTHCARE
Device Classification Name: system, x-ray, stationary
Regulation Number: 892.1680
Classification Product Code: KPR
Date Received: 07/20/2005
Decision Date: 08/09/2005
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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