The following data is part of a premarket notification filed by Volcano Corporation with the FDA for In Vision Gold With Spin Vision, Model 891 Sv.
| Device ID | K052348 |
| 510k Number | K052348 |
| Device Name: | IN VISION GOLD WITH SPIN VISION, MODEL 891 SV |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | VOLCANO CORPORATION 2870 KILGORE RD. Rancho Cordova, CA 95670 |
| Contact | Jennifer M Motto |
| Correspondent | Jennifer M Motto 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 | 2005-08-29 |
| Decision Date | 2005-12-02 |
| Summary: | summary |