Name: Predicase
Price: 199 USD

K-number	K150037
Device name	Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities
Applicant	Sensus Healthcare
Product code	JAD
Device class	Class II
Decision date	Oct 16, 2015
Decision	Substantially Equivalent
Regulation	892.5900

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Source

View the full FDA submission: accessdata.fda.gov

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Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities

Everything you need for a 510(k) submission. Nothing you don't.