The following data is part of a premarket notification filed by Empiric Systems, Llc with the FDA for Encompass.net.
| Device ID | K053455 |
| 510k Number | K053455 |
| Device Name: | ENCOMPASS.NET |
| Classification | System, Image Processing, Radiological |
| Applicant | EMPIRIC SYSTEMS, LLC 1600 MANCHESTER WAY Corinth, TX 76210 |
| Contact | Carl Alletto |
| Correspondent | Carl Alletto EMPIRIC SYSTEMS, LLC 1600 MANCHESTER WAY Corinth, TX 76210 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-09 |
| Decision Date | 2006-01-25 |
| Summary: | summary |