The following data is part of a premarket notification filed by Edan Instruments Inc with the FDA for Acclarix Lx8 Diagnostic Ultrasound System.
| Device ID | K162055 |
| 510k Number | K162055 |
| Device Name: | Acclarix LX8 Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | EDAN INSTRUMENTS INC 3/F - B, NANSHAN MEDICAL EQUIPMENTS PARK NANHAI RD 1019# Shenzhen, CN 518067 |
| Contact | Alice Yang |
| 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 | 2016-07-25 |
| Decision Date | 2017-01-31 |
| Summary: | summary |