The following data is part of a premarket notification filed by Merge Healthcare Incorporated with the FDA for Merge Pacs.
| Device ID | K192455 |
| 510k Number | K192455 |
| Device Name: | Merge PACS |
| Classification | System, Image Processing, Radiological |
| Applicant | Merge Healthcare Incorporated 900 Walnut Ridge Drive Hartland, WI 53209 |
| Contact | Amy Tannenbaum |
| Correspondent | Amy Tannenbaum Merge Healthcare Incorporated 900 Walnut Ridge Drive Hartland, WI 53209 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-09-09 |
| Decision Date | 2019-10-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842000100805 | K192455 | 000 |