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FDA 510(k), K080930, MODIFICATION TO AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS
FDA 510(k), K080930, MODIFICATION TO AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS
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510(K) Number: K080930
Device Name: MODIFICATION TO AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS
Manufacturer: U-SYSTEM, INC.
Device Classification Name: system, imaging, pulsed echo, ultrasonic
Regulation Number: 892.1560
Classification Product Code: IYO
Date Received: 04/02/2008
Decision Date: 08/07/2008
Regulation Medical Specialty: Radiology
Device Name: MODIFICATION TO AUTOMATED BREAST ULTRASOUND SYSTEM, MODEL ABUS
Manufacturer: U-SYSTEM, INC.
Device Classification Name: system, imaging, pulsed echo, ultrasonic
Regulation Number: 892.1560
Classification Product Code: IYO
Date Received: 04/02/2008
Decision Date: 08/07/2008
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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