Illuminator, Radiographic-Film
FDA product code IXC · Class I (low risk) · 21 CFR 892.1890 · Radiology
18510(k) clearances
0PMA approvals
0recalls
Manufacturers
- Med-Western Electronics, Inc. 3
- Smartlight, Ltd. 2
- Medical Synergy 1
- Sybron Corp. 1
- Sandhill 1
- General Electric Co. 1
- Diversified Diagnostic Products, Inc. 1
- Excel Medical Products, Inc. 1
- American Medical Sales, Inc. 1
- A & S Trading Co. 1
- Adp , Ltd. 1
- Voxel 1
- Lily Imaging Solutions Co. 1
- Focused Viewer, Inc. 1
- Arnold & Richter Cine Technik 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K991302 | Smartlight Digital Film Viewer, Models SL 4000PLUS, SL 2000PLUSIXC · Traditional | Smartlight, Inc. | 06/01/1999SE |
| K973965 | Smart Motorized ViewerIXC · Traditional | Smartlight, Ltd. | 12/12/1997SE |
| K973115 | Arripro 35 St/TvIXC · Traditional | Arnold & Richter Cine Technik | 09/02/1997SE |
| K970240 | Diffuser PanelIXC · Traditional | Focused Viewer, Inc. | 03/11/1997SE |
| K954998 | Lily Dark ViewerIXC · Traditional | Lily Imaging Solutions Co. | 01/29/1996SE |
| K954199 | VoxboxIXC · Traditional | Voxel | 09/29/1995SE |
| K952188 | Adviewer 2000IXC · Traditional | Adp , Ltd. | 05/30/1995SE |
| K922848 | Ultralite X-Ray Film IlluminatorIXC · Traditional | A & S Trading Co. | 09/28/1992SE |
| K922079 | Rotolux, Selectolux, ShuttervueIXC · Traditional | American Medical Sales, Inc. | 06/16/1992SE |
| K883702 | Excelview IlluminatorIXC · Traditional | Excel Medical Products, Inc. | 09/19/1988SE |
| K875233 | Variviewer (X-Ray Film Viewer)IXC · Traditional | Diversified Diagnostic Products, Inc. | 01/19/1988SE |
| K872245 | Proview (E7015) & Prolink Image Display SystemIXC · Traditional | General Electric Co. | 06/19/1987SE |
| K854933 | Sandhill Electronic CaliperIXC · Traditional | Sandhill | 02/12/1986SE |
| K840607 | LF Motorized Radiographic Film ViewerIXC · Traditional | Sybron Corp. | 03/05/1984SE |
| K812152 | Medi ViewIXC · Traditional | Medical Synergy | 09/09/1981SE |
| K802217 | View-Lite, Model-SlIXC · Traditional | Med-Western Electronics, Inc. | 10/23/1980SE |
| K802216 | View-Lite, Model-DlIXC · Traditional | Med-Western Electronics, Inc. | 10/23/1980SE |
| K802215 | View-Lite, Model-SIXC · Traditional | Med-Western Electronics, Inc. | 10/23/1980SE |