The following data is part of a premarket notification filed by Ultrasonix Medical Corporation with the FDA for Sonix Ultrasound Scanner.
| Device ID | K093462 |
| 510k Number | K093462 |
| Device Name: | SONIX ULTRASOUND SCANNER |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | UltraSonix Medical Corporation 130-4311 VIKING WAY Richmond, British Columbia, CA V6v 2k9 |
| Contact | Chas Yu |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | ITX |
| Subsequent Product Code | IYN |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2009-11-06 |
| Decision Date | 2009-11-20 |
| Summary: | summary |