IWZ · Film, Radiographic
Radiology · 21 CFR 892.1840 · Class 1
Overview
| Product Code | IWZ |
|---|---|
| Device Name | Film, Radiographic |
| Regulation | 21 CFR 892.1840 |
| Device Class | Class 1 |
| Review Panel | Radiology |
Identification
Radiographic film is a device that consists of a thin sheet of radiotransparent material coated on one or both sides with a photographic emulsion intended to record images during diagnostic radiologic procedures.
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 the limitations in § 892.9.
Recent Cleared Devices (20 of 34)
Showing 20 most recent of 34 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K970154 | KODAK EKTASIAN HG FILM (EHG-15) | Eastman Kodak Company | Apr 4, 1997 | SESE |
| K954200 | VOXGRAM | Voxel | Sep 29, 1995 | SESE |
| K931604 | 3M MEDICAL DIAGNOSTIC VIDEOCASSETTE | 3M Health Care, Ltd. | Jul 21, 1993 | SESE |
| K931605 | 3M MEDICAL DIAGNOSTIC SUPER VHS VIDEOCASSETTE | 3M Health Care, Ltd. | Jul 20, 1993 | SESE |
| K920539 | ORWO X-RAY FILM | Burkhart Roentgen Intl., Inc. | Jun 30, 1992 | SESE |
| K884827 | KODAK DENTAL BARRIER PAC | Eastman Kodak Company | Jan 30, 1989 | SESE |
| K862944 | KODAK CFT FILM SO-141 | Eastman Kodak Company | Aug 12, 1986 | SESE |
| K862415 | TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM | Parexel Intl. Corp. | Jul 1, 1986 | SESE |
| K860797 | MEDICAL X-RAY FILM | India-America Trading Co. | Mar 13, 1986 | SESE |
| K844554 | BELMONT AUTOPAN-PANORAMIC 098 CEPHALOMETRIC-RADIOG | Belmont Equipment Corp. | Feb 21, 1985 | SESE |
| K840806 | FR MEDICAL X-RAY FILM | Fr Medical/Fr Chemicals | Apr 24, 1984 | SESE |
| K840698 | POWERMAT VRP-1 X-RAY IMAGING | Powers Chemco, Inc. | Mar 16, 1984 | SESE |
| K834614 | WILCOR-XR RP-L MEDICAL FILM | Cea America Corp. | Mar 5, 1984 | SESE |
| K834613 | WILCOR-XR RP MEDICAL FILM | Cea America Corp. | Mar 5, 1984 | SESE |
| K834612 | WILCOR-XR RP-OG MEDICAL FILM | Cea America Corp. | Feb 27, 1984 | SESE |
| K834611 | SINGUL-XR RP NON SCREEN MED. FILM | Cea America Corp. | Feb 21, 1984 | SESE |
| K833234 | KODAK T-MAT L FILM SO-387 | Eastman Kodak Company | Oct 28, 1983 | SESE |
| K832504 | CRONEX LO-DOSE MAMMOGRAPHY | E.I. Dupont DE Nemours & Co., Inc. | Sep 12, 1983 | SESE |
| K813005 | KODAK CINEFLUOROGRAPHIC FILM SO-274 | Eastman Kodak Company | Nov 24, 1981 | SESE |
| K811352 | POLAROID TPX RADIOGRAPHIC FILM | Polaroid Corp. | Jun 18, 1981 | SESE |
Top Applicants
- Eastman Kodak Company — 17 clearances
- Cea America Corp. — 4 clearances
- 3M Health Care, Ltd. — 2 clearances
- E.I. Dupont DE Nemours & Co., Inc. — 2 clearances
- Belmont Equipment Corp. — 1 clearance
