510(k) K973965
- Device
- SMART MOTORIZED VIEWER
- Applicant
- SMARTLIGHT, LTD.
- 510(k) number
- K973965
- Product code
- IXC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-12-12
- Date received
- 1997-10-17
- Regulation
- 892.1890
- Classification name
- Illuminator, Radiographic-film
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- DAN BEN-ZEEV
- Address
- 47 Hataasiya St. Nesher IL 36602 36602
FDA Registration Numbers#
- 8043962
- 3010131137
- 3004475699
- 3015978022
- 3010373530
- 2424472
- 3005698350
- 3015223105
- 3011659880
- 2431273
- 3008559238
- 3008770655
- 3013685983
- 3030126955
- 2024949
- 2031508
- 2431224
- 1223419
Source Documents#
Other 510(k) Records For Product Code IXC #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K991302 | SMARTLIGHT DIGITAL FILM VIEWER, MODELS SL 4000PLUS, SL 2000PLUS | Smartlight, Inc. | 1999-06-01 |
| K973115 | ARRIPRO 35 ST/TV | Arnold & Richter Cine Technik | 1997-09-02 |
| K970240 | DIFFUSER PANEL | Focused Viewer, Inc. | 1997-03-11 |
| K954998 | LILY DARK VIEWER | Lily Imaging Solutions Co. | 1996-01-29 |
| K954199 | VOXBOX | Voxel | 1995-09-29 |
| K952188 | ADVIEWER 2000 | Adp , Ltd. | 1995-05-30 |
| K922848 | ULTRALITE X-RAY FILM ILLUMINATOR | A & S Trading Co. | 1992-09-28 |
| K922079 | ROTOLUX, SELECTOLUX, SHUTTERVUE | American Medical Sales, Inc. | 1992-06-16 |
| K883702 | EXCELVIEW ILLUMINATOR | Excel Medical Products, Inc. | 1988-09-19 |
| K875233 | VARIVIEWER (X-RAY FILM VIEWER) | Diversified Diagnostic Products, Inc. | 1988-01-19 |
| K872245 | PROVIEW (E7015) & PROLINK IMAGE DISPLAY SYSTEM | General Electric Co. | 1987-06-19 |
| K854933 | SANDHILL ELECTRONIC CALIPER | Sandhill | 1986-02-12 |
| K840607 | LF MOTORIZED RADIOGRAPHIC FILM VIEWER | Sybron Corp. | 1984-03-05 |
| K812152 | MEDI VIEW | Medical Synergy | 1981-09-09 |
| K802215 | VIEW-LITE, MODEL-S | Med-Western Electronics, Inc. | 1980-10-23 |
Legacy Summary#
summary
FDA Review#
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