The following data is part of a premarket notification filed by Medison Co., Ltd. with the FDA for Accuvix Xq Diagnostic Ultrasound System.
| Device ID | K052911 |
| 510k Number | K052911 |
| Device Name: | ACCUVIX XQ DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | MEDISON CO., LTD. 997-10 DAECHI-DONG KANGNANM-KU Seoul, KR 135-280 |
| Contact | Shim Kyung-am |
| Correspondent | Neil E Devine INTERTEK TESTING SERVICES 70 CODMAN HILL RD. Boxborough, MA 01719 |
| 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 | 2005-10-17 |
| Decision Date | 2005-10-31 |
| Summary: | summary |