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FDA 510(k), K223726, Aquilion Precision (TSX-304A/4) V10.14 with AiCE
FDA 510(k), K223726, Aquilion Precision (TSX-304A/4) V10.14 with AiCE
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510(K) Number: K223726
Device Name: Aquilion Precision (TSX-304A/4) V10.14 with AiCE
Manufacturer: Paul Biggins
Device Classification Name: System, X-Ray, Tomography, Computed
Regulation Number: JAK
Classification Product Code: 12/13/2022
Date Received: 03/07/2023
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: Aquilion Precision (TSX-304A/4) V10.14 with AiCE
Manufacturer: Paul Biggins
Device Classification Name: System, X-Ray, Tomography, Computed
Regulation Number: JAK
Classification Product Code: 12/13/2022
Date Received: 03/07/2023
Decision Date: Substantially Equivalent (SESE)
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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