The following data is part of a premarket notification filed by Chison Medical Imaging Co., Ltd. with the FDA for Sonotouch Series Diagnostic Ultrasound Systems.
| Device ID | K121867 |
| 510k Number | K121867 |
| Device Name: | SONOTOUCH SERIES DIAGNOSTIC ULTRASOUND SYSTEMS |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | CHISON MEDICAL IMAGING CO., LTD. NO. 8, XIANG NAN ROAD SHUO FANG, NEW DISTRICT Wuxi, CN 214142 |
| 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 | 2012-06-26 |
| Decision Date | 2012-08-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945121409674 | K121867 | 000 |
| 06945121408684 | K121867 | 000 |
| 06945121408301 | K121867 | 000 |
| 06945121408318 | K121867 | 000 |
| 06945121408325 | K121867 | 000 |
| 06945121408332 | K121867 | 000 |
| 06945121408349 | K121867 | 000 |
| 06945121408356 | K121867 | 000 |
| 06945121408363 | K121867 | 000 |
| 06945121408370 | K121867 | 000 |
| 06945121408387 | K121867 | 000 |
| 06945121408394 | K121867 | 000 |
| 06945121410717 | K121867 | 000 |