Device, Beam Limiting, X-Ray, Diagnostic
FDA product code KPW · Class II (moderate risk) · 21 CFR 892.1610 · Radiology
16510(k) clearances
0PMA approvals
0recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K093596 | Lumos, Model R 72BKPW · Traditional | Lumos, Inc. | 01/12/2010SE |
| K062788 | Collimator, Model M-38KPW · Traditional | Umi International | 12/28/2006SE |
| K030487 | R 72KPW · Traditional | Ralco S.R.L. | 08/01/2003SE |
| K954310 | BLA-800AKPW · Traditional | Toshiba Medical Systems | 10/18/1995SE |
| K946320 | R 302KPW · Traditional | Ralco S.R.L. | 05/11/1995SE |
| K914184 | P2020-8-0 Beam-Limiting DeviceKPW · Traditional | Precise Optics | 11/27/1991SE |
| K904587 | Densicomp 250KPW · Traditional | L. Keroack Co. | 01/24/1991SE |
| K904044 | TF-63SAKPW · Traditional | Toshiba America Medical Systems, In.C | 11/29/1990SE |
| K904489 | Eureka Extension CylindersKPW · Traditional | Eureka X-Ray Tube Corp. | 10/15/1990SE |
| K820306 | Ralco Collimator, Automatic RadiographicKPW · Traditional | Tecnomed, Inc. | 03/05/1982SE |
| K820305 | Ralco Collimators, Manual RadiographicKPW · Traditional | Tecnomed, Inc. | 03/04/1982SE |
| K820119 | Podioscope by ArrowKPW · Traditional | Arrow X-Ray Corp. | 02/18/1982SE |
| K811450 | Aluminum Filtration SystemKPW · Traditional | Wedge Filtration System | 07/02/1981SE |
| K791504 | Automatic Positive Beam CollimatorKPW · Traditional | Dial-X Instruments, Inc. | 09/07/1979SE |
| K781984 | Collimator, Heart ContourKPW · Traditional | Siemens Corp. | 12/04/1978SE |
| K770335 | Collimator, AutomaticKPW · Traditional | Litton Medical Systems | 02/28/1977SE |