The following data is part of a premarket notification filed by Medison Co., Ltd. with the FDA for Sonoace 4500 Diagnostic Ultrasound Imaging System.
| Device ID | K910342 |
| 510k Number | K910342 |
| Device Name: | SONOACE 4500 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | MEDISON CO., LTD. 148 YANG DUK WON-RI, NAM-MYUN, HONG CHUN-KUN Kang Won-do, KR |
| Contact | Robert D Waxham |
| Correspondent | Robert D Waxham MEDISON CO., LTD. 148 YANG DUK WON-RI, NAM-MYUN, HONG CHUN-KUN Kang Won-do, KR |
| Product Code | IYO |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-28 |
| Decision Date | 1991-08-19 |