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FDA 510(k), K210811, Dynamyx Digital Pathology Software
FDA 510(k), K210811, Dynamyx Digital Pathology Software
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510(K) Number: K210811
Device Name: Dynamyx Digital Pathology Software
Manufacturer: Richard Morroney
Device Classification Name: Digital Pathology Image Viewing And Management Software
Regulation Number: QKQ
Classification Product Code: 03/17/2021
Date Received: 03/01/2022
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Pathology
Device Name: Dynamyx Digital Pathology Software
Manufacturer: Richard Morroney
Device Classification Name: Digital Pathology Image Viewing And Management Software
Regulation Number: QKQ
Classification Product Code: 03/17/2021
Date Received: 03/01/2022
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Pathology
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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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