The following data is part of a premarket notification filed by Volcano Corporation with the FDA for Volcano Ifr Harvest Software (offline).
| Device ID | K143122 |
| 510k Number | K143122 |
| Device Name: | Volcano IFR Harvest Software (Offline) |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Volcano Corporation 3721 Valley Centre Dr Ste 500 San Diego, CA 92130 |
| Contact | Neeta Sharma |
| Correspondent | Neeta Sharma Volcano Corporation 3721 Valley Centre Dr Ste 500 San Diego, CA 92130 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-31 |
| Decision Date | 2015-02-20 |
| Summary: | summary |