The following data is part of a premarket notification filed by Edan Instruments, Inc with the FDA for Acclarix Lx8 Diagnostic Ultrasound System, Acclarix Ax8 Diagnostic Ultrasound System.
| Device ID | K180862 |
| 510k Number | K180862 |
| Device Name: | Acclarix LX8 Diagnostic Ultrasound System, Acclarix AX8 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 | Alice Yang |
| Correspondent | Alice Yang 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 | 2018-04-02 |
| Decision Date | 2018-05-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944413811867 | K180862 | 000 |
| 06944413809024 | K180862 | 000 |
| 06944413809031 | K180862 | 000 |
| 06944413809055 | K180862 | 000 |
| 06944413809062 | K180862 | 000 |
| 06944413811706 | K180862 | 000 |
| 06944413811713 | K180862 | 000 |
| 06944413811720 | K180862 | 000 |
| 06944413811737 | K180862 | 000 |
| 06944413811812 | K180862 | 000 |
| 06944413808997 | K180862 | 000 |