The following data is part of a premarket notification filed by Chison Medical Imaging Co., Ltd. with the FDA for Chison Diagnostic Ultrasound System,convex Probe,linear Probe,transvaginal Micro-convex Probe.
| Device ID | K113359 |
| 510k Number | K113359 |
| Device Name: | CHISON DIAGNOSTIC ULTRASOUND SYSTEM,CONVEX PROBE,LINEAR PROBE,TRANSVAGINAL MICRO-CONVEX PROBE |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| 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 | 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 | 2011-11-14 |
| Decision Date | 2012-02-03 |
| Summary: | summary |