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, Lincar Probe, Phased Probe.
| Device ID | K131305 |
| 510k Number | K131305 |
| Device Name: | CHISON DIAGNOSTIC ULTRASOUND SYSTEM, CONVEX PROBE, LINCAR PROBE, PHASED 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 | 2013-05-07 |
| Decision Date | 2013-08-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945121409698 | K131305 | 000 |
| B369MUS05185 | K131305 | 000 |
| B369MUS05184 | K131305 | 000 |
| B369MUS05183 | K131305 | 000 |
| B369MUS05182 | K131305 | 000 |
| B369MUS05181 | K131305 | 000 |
| B369MUS05179 | K131305 | 000 |
| B369MUS05178 | K131305 | 000 |
| B369MUS05177 | K131305 | 000 |
| B369MUS01027 | K131305 | 000 |
| 06945121407915 | K131305 | 000 |
| 06945121407991 | K131305 | 000 |
| 06945121407502 | K131305 | 000 |
| 06945121407496 | K131305 | 000 |
| 06945121407489 | K131305 | 000 |
| 06945121407472 | K131305 | 000 |
| 06945121407465 | K131305 | 000 |
| 06945121407458 | K131305 | 000 |
| 06945121407441 | K131305 | 000 |
| 06945121408158 | K131305 | 000 |
| 06945121408073 | K131305 | 000 |
| B369MUS01026 | K131305 | 000 |