The following data is part of a premarket notification filed by Edan Instruments Inc. with the FDA for Acclarix Ax8 Diagnostic Ultrasound System.
| Device ID | K161300 |
| 510k Number | K161300 |
| Device Name: | Acclarix AX8 Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | EDAN INSTRUMENTS INC. 3/F - B, NANSHAN MEDICAL EQUIPMENTS PARK, NANHAI RD 1019# Shenzhen, CN 518067 |
| Contact | Erico Li |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-09 |
| Decision Date | 2016-05-31 |
| Summary: | summary |