The following data is part of a premarket notification filed by Toshiba Medical Systems Corporation, Japan with the FDA for Aplio Xg Diagnostic Ultrasound System.
| Device ID | K103645 |
| 510k Number | K103645 |
| Device Name: | APLIO XG DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN 2441 MICHELLE DR Tustin, CA 92780 |
| Contact | Paul Biggins |
| Correspondent | Paul Biggins TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN 2441 MICHELLE DR Tustin, CA 92780 |
| Product Code | ITX |
| Subsequent Product Code | DQK |
| Subsequent Product Code | IYN |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-13 |
| Decision Date | 2011-01-12 |