The following data is part of a premarket notification filed by Chison Medical Imaging Co., Ltd. with the FDA for Chison Digital Color Doppler Ultrasound System, Convex Probe, Linear Probe, Phased Array Probe, Transvaginal.
| Device ID | K091877 |
| 510k Number | K091877 |
| Device Name: | CHISON DIGITAL COLOR DOPPLER ULTRASOUND SYSTEM, CONVEX PROBE, LINEAR PROBE, PHASED ARRAY PROBE, TRANSVAGINAL |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | CHISON MEDICAL IMAGING CO., LTD. 7263 CRONIN CIRCLE Dublin, CA 94568 |
| Contact | Bob Leiker |
| Correspondent | Bob Leiker CHISON MEDICAL IMAGING CO., LTD. 7263 CRONIN CIRCLE Dublin, CA 94568 |
| Product Code | ITX |
| Subsequent Product Code | IYN |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-23 |
| Decision Date | 2009-09-02 |
| Summary: | summary |