The following data is part of a premarket notification filed by Edan Instruments, Inc with the FDA for Acclarix Ax4 Diagnostic Ultrasound System.
| Device ID | K171900 |
| 510k Number | K171900 |
| Device Name: | Acclarix AX4 Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | Edan Instruments, Inc #15 Jinhui Road,Jinsha Community Kengzi Sub-District Pingshan District Shenzhen, CN 518122 |
| Contact | Crystal Cai |
| Correspondent | Doug Worth Edan Medical 1200 Crossman Ave. Suite 200 Sunnyvale, CA 94089 |
| 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 | 2017-06-26 |
| Decision Date | 2017-08-18 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944413809000 | K171900 | 000 |
| 06944413808867 | K171900 | 000 |