Submission Details
| 510(k) Number | K123893 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 18, 2012 |
| Decision Date | March 04, 2013 |
| Days to Decision | 76 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
CURA COLLIMATOR
Mar 2013
Decision
76d
Days
Class 2
Risk
About This 510(k) Submission
K123893 is an FDA 510(k) clearance for the CURA COLLIMATOR, 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 March 4, 2013, 76 days after receiving the submission on December 18, 2012. 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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