The following data is part of a premarket notification filed by Chison Medical Imaging Co., Ltd. with the FDA for Ebit Series Diagnostic Ultrasound System.
| Device ID | K162172 |
| 510k Number | K162172 |
| Device Name: | EBit Series Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | CHISON MEDICAL IMAGING CO., LTD. NO.228, CHANGJIANG EAST ROAD, BLOCK 51 AND 53, PHASE 5 INDUSTRIAL PARK SHOUFA Wuxi, CN 214142 |
| Contact | Qifei Liu |
| Correspondent | Bob Leiker LEIKER REGULATORY & QUALITY CONSULTING 4157 NORTH DEL REY AVE Clovis, CA 93619 |
| 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 | 2016-08-03 |
| Decision Date | 2016-09-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945121410861 | K162172 | 000 |
| 06945121410175 | K162172 | 000 |
| 06945121410168 | K162172 | 000 |
| 06945121410144 | K162172 | 000 |
| 06945121410137 | K162172 | 000 |
| 06945121410120 | K162172 | 000 |
| 06945121410113 | K162172 | 000 |
| 06945121410106 | K162172 | 000 |
| 06945121410090 | K162172 | 000 |
| 06945121410083 | K162172 | 000 |
| 06945121410076 | K162172 | 000 |
| 06945121410069 | K162172 | 000 |
| 06945121410052 | K162172 | 000 |
| 06945121410045 | K162172 | 000 |
| 06945121410038 | K162172 | 000 |
| 06945121409704 | K162172 | 000 |
| 06945121412889 | K162172 | 000 |
| 06945121410182 | K162172 | 000 |
| 06945121410199 | K162172 | 000 |
| 06945121410854 | K162172 | 000 |
| 06945121410670 | K162172 | 000 |
| 06945121410342 | K162172 | 000 |
| 06945121410335 | K162172 | 000 |
| 06945121410328 | K162172 | 000 |
| 06945121410311 | K162172 | 000 |
| 06945121410304 | K162172 | 000 |
| 06945121410298 | K162172 | 000 |
| 06945121410281 | K162172 | 000 |
| 06945121410274 | K162172 | 000 |
| 06945121410250 | K162172 | 000 |
| 06945121410243 | K162172 | 000 |
| 06945121410236 | K162172 | 000 |
| 06945121410229 | K162172 | 000 |
| 06945121410212 | K162172 | 000 |
| 06945121410205 | K162172 | 000 |
| 06945121414494 | K162172 | 000 |