IWZ — Film, Radiographic Class I
FDA product code IWZ covers "Film, Radiographic", a Class I medical device regulated under 21 CFR 892.1840. Submissions are reviewed by the Radiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- IWZ
- Device Class
- Class I
- Regulation Number
- 892.1840
- Submission Type
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K970154 | eastman kodak | KODAK EKTASIAN HG FILM (EHG-15) | April 4, 1997 |
| K954200 | voxel | VOXGRAM | September 29, 1995 |
| K931604 | 3m health care | 3M MEDICAL DIAGNOSTIC VIDEOCASSETTE | July 21, 1993 |
| K931605 | 3m health care | 3M MEDICAL DIAGNOSTIC SUPER VHS VIDEOCASSETTE | July 20, 1993 |
| K920539 | burkhart roentgen intl | ORWO X-RAY FILM | June 30, 1992 |
| K884827 | eastman kodak | KODAK DENTAL BARRIER PAC | January 30, 1989 |
| K862944 | eastman kodak | KODAK CFT FILM SO-141 | August 12, 1986 |
| K862415 | parexel intl | TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM | July 1, 1986 |
| K860797 | india-america trading | MEDICAL X-RAY FILM | March 13, 1986 |
| K844554 | belmont equipment | BELMONT AUTOPAN-PANORAMIC 098 CEPHALOMETRIC-RADIOG | February 21, 1985 |
| K840806 | fr medical/fr chemicals | FR MEDICAL X-RAY FILM | April 24, 1984 |
| K840698 | powers chemco | POWERMAT VRP-1 X-RAY IMAGING | March 16, 1984 |
| K834614 | cea america | WILCOR-XR RP-L MEDICAL FILM | March 5, 1984 |
| K834613 | cea america | WILCOR-XR RP MEDICAL FILM | March 5, 1984 |
| K834612 | cea america | WILCOR-XR RP-OG MEDICAL FILM | February 27, 1984 |
| K834611 | cea america | SINGUL-XR RP NON SCREEN MED. FILM | February 21, 1984 |
| K833234 | eastman kodak | KODAK T-MAT L FILM SO-387 | October 28, 1983 |
| K832504 | e.i. dupont de nemours and co | CRONEX LO-DOSE MAMMOGRAPHY | September 12, 1983 |
| K813005 | eastman kodak | KODAK CINEFLUOROGRAPHIC FILM SO-274 | November 24, 1981 |
| K811352 | polaroid | POLAROID TPX RADIOGRAPHIC FILM | June 18, 1981 |