The following data is part of a premarket notification filed by Edan Instruments, Inc. with the FDA for Acclarix Diagnostic Ultrasound System.
| Device ID | K150999 |
| 510k Number | K150999 |
| Device Name: | Acclarix Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | EDAN INSTRUMENTS, INC. 3/F-B, NANSHAN MEDICAL EQUIPMENTS PARK, NANHAI RD 1019# Shekou, CN 518067 |
| Contact | Queena Chen |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| 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 | Yes |
| Combination Product | No |
| Date Received | 2015-04-15 |
| Decision Date | 2015-05-06 |
| Summary: | summary |