The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Acclarix Ax4 Diagnostic Ultrasound System / Acclarix Lx4 Diagnostic Ultrasound System.
| Device ID | K190186 |
| 510k Number | K190186 |
| Device Name: | Acclarix AX4 Diagnostic Ultrasound System / Acclarix LX4 Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | Edan Instruments, Inc. #15 Jinhui Road, Jinsha Community, Kengzi Sub-District Pingshan District Shenzhen, CN 518122 |
| Contact | Melody Huang |
| Correspondent | Melody Huang Edan Instruments, Inc. #15 Jinhui Road, Jinsha Community, Kengzi Sub-District Pingshan District Shenzhen, CN 518122 |
| Product Code | IYO |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYN |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-01 |
| Decision Date | 2019-03-28 |
| Summary: | summary |