Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities— 510(k) K150037
Substantially EquivalentSensus Healthcare
FDA 510(k) clearance K150037 for Sensus Healthcare Superficial X-ray Radiation Therapy System with Ultrasonic Imaging Capabilities, Substantially Equivalent on 2015-10-16. Applicant: Sensus Healthcare. Device class: 2.
Clearance details
- Applicant
- Sensus Healthcare
- Product code
- Code JAD
- Device class
- Class 2
- Regulation
- 21 CFR 892.5900
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Boca Raton, FL, US
Recent devices under product code JAD
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view allRecalls naming K150037
K-number listed on FDA's recall recordMatched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K150037.
Data sourced from openFDA. This site is unofficial and independent of the FDA.