The following data is part of a premarket notification filed by Medison Co., Ltd. with the FDA for Sonoace X8 Diagnostic Ultrasound System.
| Device ID | K063580 |
| 510k Number | K063580 |
| Device Name: | SONOACE X8 DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | MEDISON CO., LTD. 1003, DAECHI-DONG GANGNANM-GU Seoul, KR 135-280 |
| Contact | Kyung-am Shim |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| 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 | Yes |
| Combination Product | No |
| Date Received | 2006-11-30 |
| Decision Date | 2006-12-14 |
| Summary: | summary |