IXC · Illuminator, Radiographic-Film
Radiology · 21 CFR 892.1890 · Class 1
Overview
| Product Code | IXC |
|---|---|
| Device Name | Illuminator, Radiographic-Film |
| Regulation | 21 CFR 892.1890 |
| Device Class | Class 1 |
| Review Panel | Radiology |
Identification
A radiographic film illuminator is a device containing a visible light source covered with a translucent front that is intended to be used to view medical radiographs.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.
Cleared Devices (18)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K991302 | SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000PLUS | Smartlight, Inc. | Jun 1, 1999 | SESE |
| K973965 | SMART MOTORIZED VIEWER | Smartlight, Ltd. | Dec 12, 1997 | SESE |
| K973115 | ARRIPRO 35 ST/TV | Arnold & Richter Cine Technik | Sep 2, 1997 | SESE |
| K970240 | DIFFUSER PANEL | Focused Viewer, Inc. | Mar 11, 1997 | SESE |
| K954998 | LILY DARK VIEWER | Lily Imaging Solutions Co. | Jan 29, 1996 | SESE |
| K954199 | VOXBOX | Voxel | Sep 29, 1995 | SESE |
| K952188 | ADVIEWER 2000 | Adp , Ltd. | May 30, 1995 | SESE |
| K922848 | ULTRALITE X-RAY FILM ILLUMINATOR | A & S Trading Co. | Sep 28, 1992 | SESE |
| K922079 | ROTOLUX, SELECTOLUX, SHUTTERVUE | American Medical Sales, Inc. | Jun 16, 1992 | SESE |
| K883702 | EXCELVIEW ILLUMINATOR | Excel Medical Products, Inc. | Sep 19, 1988 | SESE |
| K875233 | VARIVIEWER (X-RAY FILM VIEWER) | Diversified Diagnostic Products, Inc. | Jan 19, 1988 | SESE |
| K872245 | PROVIEW (E7015) & PROLINK IMAGE DISPLAY SYSTEM | General Electric Co. | Jun 19, 1987 | SESE |
| K854933 | SANDHILL ELECTRONIC CALIPER | Sandhill | Feb 12, 1986 | SESE |
| K840607 | LF MOTORIZED RADIOGRAPHIC FILM VIEWER | Sybron Corp. | Mar 5, 1984 | SESE |
| K812152 | MEDI VIEW | Medical Synergy | Sep 9, 1981 | SESE |
| K802217 | VIEW-LITE, MODEL-SL | Med-Western Electronics, Inc. | Oct 23, 1980 | SESE |
| K802216 | VIEW-LITE, MODEL-DL | Med-Western Electronics, Inc. | Oct 23, 1980 | SESE |
| K802215 | VIEW-LITE, MODEL-S | Med-Western Electronics, Inc. | Oct 23, 1980 | SESE |
Top Applicants
- Med-Western Electronics, Inc. — 3 clearances
- Voxel — 1 clearance
- Sybron Corp. — 1 clearance
- Smartlight, Ltd. — 1 clearance
- Smartlight, Inc. — 1 clearance
