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FDA 510(k), K171356, Clarity Reveal
FDA 510(k), K171356, Clarity Reveal
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510(K) Number: K171356
Device Name: Clarity Reveal
Manufacturer: Russ Yoshinaka
Device Classification Name: System, Image Processing, Radiological
Regulation Number: LLZ
Classification Product Code: KXA
Date Received: 05/09/2017
Decision Date: 08/03/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: Clarity Reveal
Manufacturer: Russ Yoshinaka
Device Classification Name: System, Image Processing, Radiological
Regulation Number: LLZ
Classification Product Code: KXA
Date Received: 05/09/2017
Decision Date: 08/03/2017
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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