The following data is part of a premarket notification filed by Toshiba Medical Systems Coporation, Japan with the FDA for Aplio 500/400/300 Diagnostic Ultrasound System.
| Device ID | K121422 |
| 510k Number | K121422 |
| Device Name: | APLIO 500/400/300 DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN 2441 MICHELLE DR Tustin, CA 92780 |
| Contact | Charlemagne Chua |
| Correspondent | Charlemagne Chua TOSHIBA MEDICAL SYSTEMS COPORATION, JAPAN 2441 MICHELLE DR Tustin, CA 92780 |
| Product Code | IYO |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYN |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-14 |
| Decision Date | 2012-08-16 |
| Summary: | summary |