The following data is part of a premarket notification filed by Iei Technology Corp. with the FDA for Pacsmate, Model Mmd-4300c/mmd-4300cx.
| Device ID | K091687 |
| 510k Number | K091687 |
| Device Name: | PACSMATE, MODEL MMD-4300C/MMD-4300CX |
| Classification | System, Image Processing, Radiological |
| Applicant | IEI TECHNOLOGY CORP. 2904 N. BOLDT DRIVE Flagstaff, AZ 86001 |
| Contact | Jennifer Reich |
| Correspondent | Jennifer Reich IEI TECHNOLOGY CORP. 2904 N. BOLDT DRIVE Flagstaff, AZ 86001 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-06-10 |
| Decision Date | 2009-07-07 |
| Summary: | summary |