The following data is part of a premarket notification filed by Wide Corporation with the FDA for Wide 5mp (mammo) Lcd Monitor System.
| Device ID | K052312 |
| 510k Number | K052312 |
| Device Name: | WIDE 5MP (MAMMO) LCD MONITOR SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | WIDE CORPORATION 1600 MANCHESTER WAY Corinth, TX 76210 |
| Contact | Carl Alletto |
| Correspondent | Carl Alletto WIDE CORPORATION 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 | 2005-08-24 |
| Decision Date | 2005-10-07 |
| Summary: | summary |