The following data is part of a premarket notification filed by Toshiba Medical Systems Corporation with the FDA for Model Ssa-680a Xario Xg Diagnostic Ultrasound System, Version 1.00.
Device ID | K072918 |
510k Number | K072918 |
Device Name: | MODEL SSA-680A XARIO XG DIAGNOSTIC ULTRASOUND SYSTEM, VERSION 1.00 |
Classification | Transducer, Ultrasonic, Diagnostic |
Applicant | TOSHIBA MEDICAL SYSTEMS CORPORATION 2441 MICHELLE DRIVE Tustin, CA 92780 |
Contact | Paul Biggins |
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 | 2007-10-15 |
Decision Date | 2007-10-29 |
Summary: | summary |