The following data is part of a premarket notification filed by Witt Biomedical Corp with the FDA for Calysto Image Iv-image And Information Management System.
| Device ID | K040195 |
| 510k Number | K040195 |
| Device Name: | CALYSTO IMAGE IV-IMAGE AND INFORMATION MANAGEMENT SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | WITT BIOMEDICAL CORP 305 NORTH DR. Melbourne, FL 32934 |
| Contact | Elfriede Pagan |
| Correspondent | Elfriede Pagan WITT BIOMEDICAL CORP 305 NORTH DR. Melbourne, FL 32934 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-28 |
| Decision Date | 2004-04-07 |