The following data is part of a premarket notification filed by Chison Medical Imaging Co., Ltd. with the FDA for Qbit Series Diagnostic Ultrasound System.
| Device ID | K150861 |
| 510k Number | K150861 |
| Device Name: | QBit 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, SHUOFA 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 | 2015-04-01 |
| Decision Date | 2015-07-28 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06945121403269 | K150861 | 000 |
| 06945121403245 | K150861 | 000 |
| 06945121403221 | K150861 | 000 |
| 06945121414715 | K150861 | 000 |