The following data is part of a premarket notification filed by Samsung Medison Co., Ltd with the FDA for 3d/5d Viewer.
| Device ID | K151808 |
| 510k Number | K151808 |
| Device Name: | 3D/5D Viewer |
| Classification | System, Image Processing, Radiological |
| Applicant | SAMSUNG MEDISON CO., LTD 42, TEHERAN-RO 108-GIL, Gangnam-gu, KR |
| Contact | Kim Jiyoung |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2015-07-02 |
| Decision Date | 2015-07-29 |
| Summary: | summary |