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FDA 510(k), K192388, SonoVision Ultrasound Imaging System
FDA 510(k), K192388, SonoVision Ultrasound Imaging System
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510(K) Number: K192388
Device Name: SonoVision Ultrasound Imaging System
Manufacturer: Tissue Differentiation Intelligence, LLC
Device Classification Name: system, imaging, pulsed doppler, ultrasonic
Regulation Number: 892.1550
Classification Product Code: IYN
Date Received: 09/03/2019
Decision Date: 03/12/2020
Regulation Medical Specialty: Radiology
Device Name: SonoVision Ultrasound Imaging System
Manufacturer: Tissue Differentiation Intelligence, LLC
Device Classification Name: system, imaging, pulsed doppler, ultrasonic
Regulation Number: 892.1550
Classification Product Code: IYN
Date Received: 09/03/2019
Decision Date: 03/12/2020
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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