Submission Details
| 510(k) Number | K133603 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 25, 2013 |
| Decision Date | September 25, 2014 |
| Days to Decision | 304 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
Cleared
Traditional
PHILIPS CT DYNAMIC MYOCARDIAL PERFUSION (DMP) APPLICATION
Sep 2014
Decision
304d
Days
Class 2
Risk
About This 510(k) Submission
K133603 is an FDA 510(k) clearance for the PHILIPS CT DYNAMIC MYOCARDIAL PERFUSION (DMP) APPLICATION, a System, X-ray, Tomography, Computed (Class II — Special Controls, product code JAK), submitted by Philips Medical Systems (Cleveland, US). The FDA issued a Cleared decision on September 25, 2014, 304 days after receiving the submission on November 25, 2013. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.
Device Classification
| Product Code | JAK — System, X-ray, Tomography, Computed |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1750 |
Manufacturer
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