The following data is part of a premarket notification filed by Toshiba Medical Systems Corporation with the FDA for Aplio 500/400/300 Diagnostic Ultrasound System V4.0.
| Device ID | K133761 |
| 510k Number | K133761 |
| Device Name: | APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM V4.0 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | TOSHIBA MEDICAL SYSTEMS CORPORATION 2441 MICHELLE DRIVE Tustin, CA 92780 |
| Contact | Charlemagne Chua |
| Correspondent | Charlemagne Chua TOSHIBA MEDICAL SYSTEMS CORPORATION 2441 MICHELLE DRIVE Tustin, CA 92780 |
| 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 | No |
| Combination Product | No |
| Date Received | 2013-12-11 |
| Decision Date | 2014-04-22 |
| Summary: | summary |