The following data is part of a premarket notification filed by Ultrasonix Medical Corporation with the FDA for Ergosonix Ultrasound Scanner, Modulo Ultrasound Scanner.
| Device ID | K042326 |
| 510k Number | K042326 |
| Device Name: | ERGOSONIX ULTRASOUND SCANNER, MODULO ULTRASOUND SCANNER |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | UltraSonix Medical Corporation 310-3480 GILMORE WAY Burnaby, British Columbia, CA V5g 4y1 |
| Contact | Iulia Nuca |
| Correspondent | Iulia Nuca UltraSonix Medical Corporation 310-3480 GILMORE WAY Burnaby, British Columbia, CA V5g 4y1 |
| 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 | No |
| Combination Product | No |
| Date Received | 2004-08-27 |
| Decision Date | 2004-09-16 |
| Summary: | summary |