FDA 510(k), K150037, Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities

FDA 510(k), K150037, Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities

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510(K) Number: K150037
Device Name: Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities
Manufacturer: KAL FISHERMAN
Device Classification Name: System, Therapeutic, X-Ray
Regulation Number: JAD
Classification Product Code: KXA
Date Received: 01/09/2015
Decision Date: 10/16/2015
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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