The following data is part of a premarket notification filed by Chison Medical Technologies Co., Ltd. with the FDA for Xbit Series Digital Color Doppler Ultrasound System.
| Device ID | K200780 |
| 510k Number | K200780 |
| Device Name: | XBit Series Digital Color Doppler Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | CHISON Medical Technologies Co., Ltd. No.228, Changjiang East Road, Block 51 And 53, Phase 5, Shuofang Industrial Park Wuxi, CN 214142 |
| Contact | Qifei Liu |
| Correspondent | Qifei Liu CHISON Medical Technologies Co., Ltd. No.228, Changjiang East Road, Block 51 And 53, Phase 5, Shuofang Industrial Park 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 | No |
| Combination Product | No |
| Date Received | 2020-03-25 |
| Decision Date | 2020-08-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945121413398 | K200780 | 000 |
| 06945121413657 | K200780 | 000 |
| 06945121413770 | K200780 | 000 |
| 06945121413763 | K200780 | 000 |
| 06945121413794 | K200780 | 000 |
| 06945121414029 | K200780 | 000 |
| 06945121414005 | K200780 | 000 |
| 06945121414135 | K200780 | 000 |
| 06945121414272 | K200780 | 000 |
| 06945121414265 | K200780 | 000 |
| 06945121413602 | K200780 | 000 |
| 06945121413527 | K200780 | 000 |
| 06945121413534 | K200780 | 000 |
| 06945121413367 | K200780 | 000 |
| 06945121413343 | K200780 | 000 |
| 06945121413329 | K200780 | 000 |
| 06945121413312 | K200780 | 000 |
| 06945121413350 | K200780 | 000 |
| 06945121413336 | K200780 | 000 |
| 06945121413473 | K200780 | 000 |
| 06945121413466 | K200780 | 000 |
| 06945121413480 | K200780 | 000 |
| 06945121415385 | K200780 | 000 |