The following data is part of a premarket notification filed by Fujifilm Sonosite, Inc. with the FDA for Sonosite Sii Ultrasound System, Sonosite Edge Ii Ultrasound System.
| Device ID | K162045 |
| 510k Number | K162045 |
| Device Name: | SonoSite SII Ultrasound System, SonoSite Edge II Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | FUJIFILM SonoSite, Inc. 21919 30th Drive SE Bothell, WA 98021 -3904 |
| Contact | Jordan Grimmer |
| 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 | 2016-07-25 |
| Decision Date | 2016-08-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00841517105013 | K162045 | 000 |
| 00841517108120 | K162045 | 000 |
| 00841517109202 | K162045 | 000 |
| 00841517109691 | K162045 | 000 |
| 00841517109639 | K162045 | 000 |
| 00841517109622 | K162045 | 000 |
| 00841517109592 | K162045 | 000 |
| 00841517109936 | K162045 | 000 |
| 00841517109929 | K162045 | 000 |
| 00841517109752 | K162045 | 000 |
| 00841517109110 | K162045 | 000 |
| 00841517109028 | K162045 | 000 |
| 00841517108137 | K162045 | 000 |
| 00841517107963 | K162045 | 000 |
| 00841517105990 | K162045 | 000 |
| 00841517104986 | K162045 | 000 |
| 00841517105587 | K162045 | 000 |
| 00841517104948 | K162045 | 000 |
| 00841517104931 | K162045 | 000 |
| 00841517104924 | K162045 | 000 |
| 00841517104917 | K162045 | 000 |
| 00841517104870 | K162045 | 000 |
| 00841517104856 | K162045 | 000 |
| 00841517105648 | K162045 | 000 |
| 00841517106157 | K162045 | 000 |
| 00841517106140 | K162045 | 000 |
| 00841517110154 | K162045 | 000 |