The following data is part of a premarket notification filed by Fujifilm Sonosite, Inc. with the FDA for Sonosite Iviz Ultrasound System.
| Device ID | K162288 |
| 510k Number | K162288 |
| Device Name: | SonoSite IViz Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | FUJIFILM SONOSITE, INC. 21919 30TH DRIVE SE Bothell, WA 98021 -3904 |
| Contact | Patricia Liau |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2016-08-15 |
| Decision Date | 2016-09-08 |
| Summary: | summary |