The following data is part of a premarket notification filed by Merge Healthcare Incorporated with the FDA for Merge Pacs.
| Device ID | K173475 |
| 510k Number | K173475 |
| Device Name: | Merge PACS |
| Classification | System, Image Processing, Radiological |
| Applicant | Merge Healthcare Incorporated 900 Walnut Ridge Drive Hartland, WI 53029 |
| Contact | Carol Nakagawa |
| Correspondent | Carol Nakagawa Merge Healthcare Incorporated 900 Walnut Ridge Drive Hartland, WI 53029 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-09 |
| Decision Date | 2017-12-08 |
| Summary: | summary |