The following data is part of a premarket notification filed by Ultrasonix Medical Corporation with the FDA for Sonixtablet Ultrasound Scanner.
Device ID | K113663 |
510k Number | K113663 |
Device Name: | SONIXTABLET ULTRASOUND SCANNER |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
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 | IYN |
CFR Regulation Number | 892.1550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2011-12-13 |
Decision Date | 2012-01-25 |
Summary: | summary |