The following data is part of a premarket notification filed by Fujifilm Sonosite,inc. with the FDA for Fujifilm Sonosite Iviz Ultrasound System.
| Device ID | K152983 |
| 510k Number | K152983 |
| Device Name: | FUJIFILM SonoSite IViz Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | FUJIFILM SONOSITE,INC. 21919 30th Dr 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 | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2015-10-09 |
| Decision Date | 2015-11-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841517105136 | K152983 | 000 |
| 00841517108311 | K152983 | 000 |
| 00841517106683 | K152983 | 000 |
| 00841517106690 | K152983 | 000 |
| 00841517106676 | K152983 | 000 |
| 00841517104313 | K152983 | 000 |
| 00841517105150 | K152983 | 000 |
| 00841517105167 | K152983 | 000 |
| 00841517104030 | K152983 | 000 |
| 00841517104047 | K152983 | 000 |
| 00841517104566 | K152983 | 000 |
| 00841517108564 | K152983 | 000 |