Submission Details
| 510(k) Number | K131150 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 23, 2013 |
| Decision Date | July 30, 2013 |
| Days to Decision | 98 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
CURA COMPENSATOR
Jul 2013
Decision
98d
Days
Class 2
Risk
About This 510(k) Submission
K131150 is an FDA 510(k) clearance for the CURA COMPENSATOR, a Block, Beam-shaping, Radiation Therapy (Class II — Special Controls, product code IXI), submitted by Cura Medical Technologies, LLC (Lake Forest, US). The FDA issued a Cleared decision on July 30, 2013, 98 days after receiving the submission on April 23, 2013. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5710.
Device Classification
| Product Code | IXI — Block, Beam-shaping, Radiation Therapy |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.5710 |
Manufacturer
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