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FDA 510(k), K211222, qER-Quant
FDA 510(k), K211222, qER-Quant
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$149.00 USD
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510(K) Number: K211222
Device Name: qER-Quant
Manufacturer: Qure.ai Technologies
Device Classification Name: Automated Radiological Image Processing Software
Regulation Number: 892.2050
Classification Product Code: QIH
Date Received: 04/23/2021
Decision Date: 07/30/2021
Regulation Medical Specialty: Radiology
Device Name: qER-Quant
Manufacturer: Qure.ai Technologies
Device Classification Name: Automated Radiological Image Processing Software
Regulation Number: 892.2050
Classification Product Code: QIH
Date Received: 04/23/2021
Decision Date: 07/30/2021
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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