The following data is part of a premarket notification filed by Samsung Medison Co., Ltd. with the FDA for 5d Viewer.
| Device ID | K161955 |
| 510k Number | K161955 |
| Device Name: | 5D Viewer |
| Classification | System, Image Processing, Radiological |
| Applicant | SAMSUNG Medison Co., Ltd. 42, Teheran-ro 108-gil Gagnam-gu Seoul, KR |
| Contact | Kyeong-mi Park |
| 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 | 2016-07-18 |
| Decision Date | 2016-08-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08806167761172 | K161955 | 000 |