Product code IWZ
- Device name
- Film, Radiographic
- Medical specialty
- Radiology
- Device class
- 1
- Regulation number
- 892.1840
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K970154 | KODAK EKTASIAN HG FILM (EHG-15) | Eastman Kodak Company | 1997-04-04 |
| K954200 | VOXGRAM | Voxel | 1995-09-29 |
| K931604 | 3M MEDICAL DIAGNOSTIC VIDEOCASSETTE | 3M Health Care, Ltd. | 1993-07-21 |
| K931605 | 3M MEDICAL DIAGNOSTIC SUPER VHS VIDEOCASSETTE | 3M Health Care, Ltd. | 1993-07-20 |
| K920539 | ORWO X-RAY FILM | Burkhart Roentgen Intl., Inc. | 1992-06-30 |
| K884827 | KODAK DENTAL BARRIER PAC | Eastman Kodak Company | 1989-01-30 |
| K862944 | KODAK CFT FILM SO-141 | Eastman Kodak Company | 1986-08-12 |
| K862415 | TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM | Parexel Intl. Corp. | 1986-07-01 |
| K860797 | MEDICAL X-RAY FILM | India-America Trading Co. | 1986-03-13 |
| K844554 | BELMONT AUTOPAN-PANORAMIC 098 CEPHALOMETRIC-RADIOG | Belmont Equipment Corp. | 1985-02-21 |
| K840806 | FR MEDICAL X-RAY FILM | Fr Medical/Fr Chemicals | 1984-04-24 |
| K840698 | POWERMAT VRP-1 X-RAY IMAGING | Powers Chemco, Inc. | 1984-03-16 |
| K834614 | WILCOR-XR RP-L MEDICAL FILM | Cea America Corp. | 1984-03-05 |
| K834613 | WILCOR-XR RP MEDICAL FILM | Cea America Corp. | 1984-03-05 |
| K834612 | WILCOR-XR RP-OG MEDICAL FILM | Cea America Corp. | 1984-02-27 |
| K834611 | SINGUL-XR RP NON SCREEN MED. FILM | Cea America Corp. | 1984-02-21 |
| K833234 | KODAK T-MAT L FILM SO-387 | Eastman Kodak Company | 1983-10-28 |
| K832504 | CRONEX LO-DOSE MAMMOGRAPHY | E.I. Dupont DE Nemours & Co., Inc. | 1983-09-12 |
| K813005 | KODAK CINEFLUOROGRAPHIC FILM SO-274 | Eastman Kodak Company | 1981-11-24 |
| K811352 | POLAROID TPX RADIOGRAPHIC FILM | Polaroid Corp. | 1981-06-18 |
| K802171 | KODAK ORTHO L FILM | Eastman Kodak Company | 1980-10-31 |
| K800901 | KODAK EKTASPEED DENTAL X-RAY FILM | Eastman Kodak Company | 1980-05-20 |
| K800134 | HOPE MODEL 126, AUTO/PROCES., DEN. FLM | Hope Industries, Inc. | 1980-05-02 |
| K792448 | KODAK X-OMAT G FILM | Eastman Kodak Company | 1980-01-09 |
| K792178 | KODAK CFN FILM SO-224 | Eastman Kodak Company | 1980-01-09 |
| K792293 | KODAK ORTHO G FILM | Eastman Kodak Company | 1980-01-09 |
| K792317 | SR 301 MEDICAL X-RAY FILM | E.I. Dupont DE Nemours & Co., Inc. | 1980-01-09 |
| K792434 | KODAK X-OMAT M20 PROCESSOR, MODEL 2 | Eastman Kodak Company | 1980-01-09 |
| K792435 | KODAK X-OMAT M20 PROCESSOR, MODEL 1 | Eastman Kodak Company | 1980-01-09 |
| K792517 | KODAK X-OMAT RP FILM | Eastman Kodak Company | 1980-01-09 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06430035874644 | Imaging Plates | PaloDEx Group Oy | 2024-02-22 |
| 06430035875061 | Imaging Plates | PaloDEx Group Oy | 2024-02-22 |
| 06430035875054 | Imaging Plates | PaloDEx Group Oy | 2024-02-22 |
| 06430035875047 | Imaging Plates | PaloDEx Group Oy | 2024-02-22 |
| 06430035875030 | Imaging Plates | PaloDEx Group Oy | 2024-02-22 |
| 06430035875023 | Imaging Plates | PaloDEx Group Oy | 2024-02-22 |
| 06430035875016 | Imaging Plates | PaloDEx Group Oy | 2024-02-22 |
| 06430035875009 | Imaging Plates | PaloDEx Group Oy | 2024-02-22 |
| 06430035874705 | Imaging Plates | PaloDEx Group Oy | 2024-02-22 |
| 06430035874699 | Imaging Plates | PaloDEx Group Oy | 2024-02-22 |
| 06430035874682 | Imaging Plates | PaloDEx Group Oy | 2024-02-22 |
| 06430035874675 | Imaging Plates | PaloDEx Group Oy | 2024-02-22 |
| 06430035874668 | Imaging Plates | PaloDEx Group Oy | 2024-02-22 |
| 06430035874651 | Imaging Plates | PaloDEx Group Oy | 2024-02-22 |
| 06430035874637 | Imaging Plates | PaloDEx Group Oy | 2024-02-22 |
| 06430035874996 | Imaging Plates | PaloDEx Group Oy | 2024-02-22 |
| H65811253101 | Henry Schein | HENRY SCHEIN, INC. | 2020-06-18 |
| H65811253331 | Henry Schein | HENRY SCHEIN, INC. | 2020-06-18 |
| H65890042830 | Henry Schein | HENRY SCHEIN, INC. | 2020-06-09 |
| H65890042840 | Henry Schein | HENRY SCHEIN, INC. | 2020-06-09 |
| H65890042850 | Henry Schein | HENRY SCHEIN, INC. | 2020-06-09 |
| H65890042860 | Henry Schein | HENRY SCHEIN, INC. | 2020-06-09 |
| H65890042870 | Henry Schein | HENRY SCHEIN, INC. | 2020-06-09 |
| H65890042880 | Henry Schein | HENRY SCHEIN, INC. | 2020-06-09 |
| H65890042890 | Henry Schein | HENRY SCHEIN, INC. | 2020-06-09 |
| H65810061070 | Henry Schein | HENRY SCHEIN, INC. | 2020-05-14 |
| H65810058710 | Henry Schein | HENRY SCHEIN, INC. | 2020-05-14 |
| H65810012430 | Henry Schein | HENRY SCHEIN, INC. | 2020-05-14 |
| 10304040040895 | Henry Schein | HENRY SCHEIN, INC. | 2019-04-03 |
| 10304040040918 | Henry Schein | HENRY SCHEIN, INC. | 2019-04-03 |