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FDA 510(k), K080555, SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS)
FDA 510(k), K080555, SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS)
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510(K) Number: K080555
Device Name: SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS)
Manufacturer: IVU IMAGING CORPORATION
Device Classification Name: transducer, ultrasonic, diagnostic
Regulation Number: 892.1570
Classification Product Code: ITX
Date Received: 02/28/2008
Decision Date: 06/03/2008
Regulation Medical Specialty: Radiology
Device Name: SOFIA AUTOMATED TOMOGRAPHIC ULTRASOUND (ATUS)
Manufacturer: IVU IMAGING CORPORATION
Device Classification Name: transducer, ultrasonic, diagnostic
Regulation Number: 892.1570
Classification Product Code: ITX
Date Received: 02/28/2008
Decision Date: 06/03/2008
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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