The following data is part of a premarket notification filed by Samsung Medison Co., Ltd. with the FDA for Rs80a Diagnostic Ultrasound System.
| Device ID | K153539 |
| 510k Number | K153539 |
| Device Name: | RS80A Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | SAMSUNG MEDISON CO., LTD. 42, TEHERAN-RO 108-GIL, GANGNAM-GU Seoul, KR |
| Contact | Kyeong-mi Park |
| Correspondent | Kyeong-mi Park SAMSUNG MEDISON CO., LTD. 42, TEHERAN-RO 108-GIL, GANGNAM-GU Seoul, KR |
| 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 | No |
| Combination Product | No |
| Date Received | 2015-12-10 |
| Decision Date | 2016-10-03 |
| Summary: | summary |