The following data is part of a premarket notification filed by Edan Instruments Inc with the FDA for Acclarix Ax8 Diagnostic Ultrasound System, Acclarix Lx8 Diagnostic Ultrasound System.
| Device ID | K171824 |
| 510k Number | K171824 |
| Device Name: | Acclarix AX8 Diagnostic Ultrasound System, Acclarix LX8 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 518067 |
| Contact | Alice Yang |
| Correspondent | Doug Worth Edan Medical 1200 Crossman Ave. Suite 200 Sunnyvale, CA 94089 |
| 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 | 2017-06-19 |
| Decision Date | 2017-07-18 |
| Summary: | summary |