The following data is part of a premarket notification filed by Toshiba America Medical Systems, Inc. with the FDA for Aplio Xg Diagnostic Ultrasound System, Model Ssa - 790a, Version 2.2.
| Device ID | K081065 |
| 510k Number | K081065 |
| Device Name: | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM, MODEL SSA - 790A, VERSION 2.2 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | TOSHIBA AMERICA MEDICAL SYSTEMS, INC. 2441 MICHELLE DR. P.O. BOX 2068 Tustin, CA 92781 -2068 |
| 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 | 2008-04-15 |
| Decision Date | 2008-06-06 |
| Summary: | summary |