The following data is part of a premarket notification filed by Axis Health Care, Llc with the FDA for Axis Pacs, Hms Pacs.
| Device ID | K103679 |
| 510k Number | K103679 |
| Device Name: | AXIS PACS, HMS PACS |
| Classification | System, Image Processing, Radiological |
| Applicant | AXIS HEALTH CARE, LLC 5755 CARMICHAEL PARKWAY Montgomery, AL 36117 |
| Contact | Ronald W Graham |
| Correspondent | Ronald W Graham AXIS HEALTH CARE, LLC 5755 CARMICHAEL PARKWAY Montgomery, AL 36117 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-12-17 |
| Decision Date | 2011-03-03 |
| Summary: | summary |