K082229 is an FDA 510(k) clearance for the S5/S5I SERIES INTRAVASCULAR IMAGING AND PRESSURE SYSTEM, COMBOMAP PRESSURE AND FLOW SYSTEM. This device is classified as a System, Imaging, Pulsed Echo, Ultrasonic (Class II - Special Controls, product code IYO).
Submitted by Volcano Corporation (Rancho Cordova,, US). The FDA issued a Cleared decision on October 8, 2008, 62 days after receiving the submission on August 7, 2008.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1560.
| 510(k) Number | K082229 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 07, 2008 |
| Decision Date | October 08, 2008 |
| Days to Decision | 62 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IYO — System, Imaging, Pulsed Echo, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1560 |