FDA 510(k), K200136, Shear Wave Quantificational Ultrasound Diagnostic System

FDA 510(k), K200136, Shear Wave Quantificational Ultrasound Diagnostic System

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510(K) Number: K200136
Device Name: Shear Wave Quantificational Ultrasound Diagnostic System
Manufacturer: Jinhua Shao
Device Classification Name: System, Imaging, Pulsed Echo, Ultrasonic
Regulation Number: IYO
Classification Product Code: KXA
Date Received: 01/21/2020
Decision Date: 03/17/2020
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
  • Status: Pending Fast-Track Request
  • Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity

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