The following data is part of a premarket notification filed by Chison Medical Imaging Co., Ltd. with the FDA for Site~rite Halcyon Diagnostic Ultrasound System.
| Device ID | K170870 |
| 510k Number | K170870 |
| Device Name: | Site~Rite Halcyon 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, ShuoFa Wuxi, CN 214142 |
| Contact | Qifei Liu |
| Correspondent | Qifei Liu CHISON Medical Imaging Co., Ltd. NO.228, ChangJiang East Road,Block 51 And 53 Phase 5 Industrial Park, ShuoFa 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 | 2017-03-23 |
| Decision Date | 2017-07-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945121412032 | K170870 | 000 |
| 06945121412056 | K170870 | 000 |