The following data is part of a premarket notification filed by Toshiba Medical Systems Corporation with the FDA for Aplio Xg Diagnostic Ultrasound System, Model Ssa-790a, Version 1.0.
| Device ID | K063130 |
| 510k Number | K063130 |
| Device Name: | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA-790A, VERSION 1.0 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| 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 | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-10-13 |
| Decision Date | 2006-11-02 |
| Summary: | summary |