The following data is part of a premarket notification filed by Ultrasonix Medical Corporation with the FDA for Sonixgps Needle Sensor.
| Device ID | K111818 |
| 510k Number | K111818 |
| Device Name: | SONIXGPS NEEDLE SENSOR |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | UltraSonix Medical Corporation 130-4311 VIKING WAY Richmond, British Columbia, CA V6v 2k9 |
| Contact | Chas Yu |
| Correspondent | William Sammons INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2011-06-28 |
| Decision Date | 2012-06-13 |
| Summary: | summary |