The following data is part of a premarket notification filed by Emageon Inc. with the FDA for Evms (enterprise Visual Medical System Software).
| Device ID | K053281 |
| 510k Number | K053281 |
| Device Name: | EVMS (ENTERPRISE VISUAL MEDICAL SYSTEM SOFTWARE) |
| Classification | System, Image Processing, Radiological |
| Applicant | EMAGEON INC. 10 WEST MIFFLIN ST. SUITE 400 Madison, WI 53704 |
| Contact | Inger L Hanson |
| Correspondent | Pedrot Gonzalez 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 | 2005-11-25 |
| Decision Date | 2005-12-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00842000100614 | K053281 | 000 |