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: 01/09/2015
Date Received: 10/16/2015
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
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: 01/09/2015
Date Received: 10/16/2015
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Radiology
- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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