The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Volcano Angio-ivus Mapping (aim) System.
| Device ID | K060483 |
| 510k Number | K060483 |
| Device Name: | VOLCANO ANGIO-IVUS MAPPING (AIM) SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | VOLCANO CORPORATION 2870 KILGORE RD. Rancho Cordova, CA 95670 |
| Contact | Michelle J Badal |
| Correspondent | Michelle J Badal VOLCANO CORPORATION 2870 KILGORE RD. Rancho Cordova, CA 95670 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-24 |
| Decision Date | 2006-06-23 |
| Summary: | summary |