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FDA 510(k), K213620, ATUSA™ Automated 3D Breast Ultrasound System
FDA 510(k), K213620, ATUSA™ Automated 3D Breast Ultrasound System
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$149.00 USD
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510(K) Number: K213620
Device Name: ATUSA™ Automated 3D Breast Ultrasound System
Manufacturer: iSono Health, Inc.
Device Classification Name: System, Imaging, Pulsed Echo, Ultrasonic
Regulation Number: 892.1560
Classification Product Code: IYO
Date Received: 11/16/2021
Decision Date: 04/22/2022
Regulation Medical Specialty: Radiology
Device Name: ATUSA™ Automated 3D Breast Ultrasound System
Manufacturer: iSono Health, Inc.
Device Classification Name: System, Imaging, Pulsed Echo, Ultrasonic
Regulation Number: 892.1560
Classification Product Code: IYO
Date Received: 11/16/2021
Decision Date: 04/22/2022
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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