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 |