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FDA 510(k), K182564, Quantib ND
FDA 510(k), K182564, Quantib ND
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510(K) Number: K182564
Device Name: Quantib ND
Manufacturer: Floor van Leeuwen
Device Classification Name: System, Image Processing, Radiological
Regulation Number: LLZ
Classification Product Code: KXA
Date Received: 09/18/2018
Decision Date: 12/27/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
Device Name: Quantib ND
Manufacturer: Floor van Leeuwen
Device Classification Name: System, Image Processing, Radiological
Regulation Number: LLZ
Classification Product Code: KXA
Date Received: 09/18/2018
Decision Date: 12/27/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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