The following data is part of a premarket notification filed by Toshiba Medical Systems Corporation, Japan with the FDA for Aplio Artida Diagnostic Ultrasound System.
| Device ID | K121577 |
| 510k Number | K121577 |
| Device Name: | APLIO ARTIDA DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN 2441 MICHELLE DR Tustin, CA 92780 |
| Contact | Charlemagne Chua |
| Correspondent | Charlemagne Chua TOSHIBA MEDICAL SYSTEMS CORPORATION, JAPAN 2441 MICHELLE DR Tustin, CA 92780 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-30 |
| Decision Date | 2012-06-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04987670000607 | K121577 | 000 |