The following data is part of a premarket notification filed by Medical Manager Research Development with the FDA for Ximx System.
| Device ID | K002100 |
| 510k Number | K002100 |
| Device Name: | XIMX SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | MEDICAL MANAGER RESEARCH DEVELOPMENT 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Contact | Jeffrey K Shapiro |
| Correspondent | Jeffrey K Shapiro MEDICAL MANAGER RESEARCH DEVELOPMENT 555 THIRTEENTH STREET, N.W. Washington, DC 20004 -1109 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-07-11 |
| Decision Date | 2000-08-25 |