SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEM— 510(k) K131582

Name: FDA 510(k) clearance K131582
Creator: U.S. Food and Drug Administration
Published: 2013-08-28

Substantially Equivalent

Sensus Healthcare

FDA 510(k) clearance K131582 for SENSUS HELTHCARE IMAGE-DUIDED SUPERFICIAL RADIOTHERAPY SYSTEM, Substantially Equivalent on 2013-08-28. 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: 2013-05-31
Decision date: 2013-08-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boca Raton, FL, US

Download summary PDF View on FDA.gov ↗

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