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FDA 510(k), K163624, Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)
FDA 510(k), K163624, Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)
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510(K) Number: K163624
Device Name: Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)
Manufacturer: Dharaben Desai
Device Classification Name: Solid State X-Ray Imager (Flat Panel/Digital Imager)
Regulation Number: MQB
Classification Product Code: KXA
Date Received: 12/22/2016
Decision Date: 06/30/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600)
Manufacturer: Dharaben Desai
Device Classification Name: Solid State X-Ray Imager (Flat Panel/Digital Imager)
Regulation Number: MQB
Classification Product Code: KXA
Date Received: 12/22/2016
Decision Date: 06/30/2017
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
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