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FDA 510(k), K212981, MirrorMe3D Modeling System
FDA 510(k), K212981, MirrorMe3D Modeling System
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510(K) Number: K212981
Device Name: MirrorMe3D Modeling System
Manufacturer: Jordan Mills
Device Classification Name: System, Image Processing, Radiological
Regulation Number: LLZ
Classification Product Code: KXA
Date Received: 09/17/2021
Decision Date: 04/22/2022
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: MirrorMe3D Modeling System
Manufacturer: Jordan Mills
Device Classification Name: System, Image Processing, Radiological
Regulation Number: LLZ
Classification Product Code: KXA
Date Received: 09/17/2021
Decision Date: 04/22/2022
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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