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FDA 510(k), K192880, InferRead Lung CT.AI
FDA 510(k), K192880, InferRead Lung CT.AI
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510(K) Number: K192880
Device Name: InferRead Lung CT.AI
Manufacturer: Beijing Infervision Technology Co.,Ltd.
Device Classification Name: Lung Computed Tomography System, Computer-Aided Detection
Regulation Number: 892.2050
Classification Product Code: OEB
Date Received: 10/09/2019
Decision Date: 07/02/2020
Regulation Medical Specialty: Radiology
Device Name: InferRead Lung CT.AI
Manufacturer: Beijing Infervision Technology Co.,Ltd.
Device Classification Name: Lung Computed Tomography System, Computer-Aided Detection
Regulation Number: 892.2050
Classification Product Code: OEB
Date Received: 10/09/2019
Decision Date: 07/02/2020
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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