KPW — Device, Beam Limiting, X-Ray, Diagnostic Class II
FDA product code KPW covers "Device, Beam Limiting, X-Ray, Diagnostic", a Class II medical device regulated under 21 CFR 892.1610. Submissions are reviewed by the Radiology panel. At least 16 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- KPW
- Device Class
- Class II
- Regulation Number
- 892.1610
- Submission Type
- 510(k) Exempt
- Review Panel
- RA
- Medical Specialty
- Radiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K093596 | Lumos | LUMOS, MODEL R 72B | Jan 12, 2010 |
| K062788 | Umi International | COLLIMATOR, MODEL M-38 | Dec 28, 2006 |
| K030487 | Ralco | R 72 | Aug 1, 2003 |
| K954310 | Toshiba Medical Systems | BLA-800A | Oct 18, 1995 |
| K946320 | Ralco | R 302 | May 11, 1995 |
| K914184 | Precise Optics | P2020-8-0 BEAM-LIMITING DEVICE | Nov 27, 1991 |
| K904587 | L. Keroack | DENSICOMP 250 | Jan 24, 1991 |
| K904044 | Toshiba America Medical Systems, In.C | TF-63SA | Nov 29, 1990 |
| K904489 | Eureka X-Ray Tube | EUREKA EXTENSION CYLINDERS | Oct 15, 1990 |
| K820306 | Tecnomed | RALCO COLLIMATOR, AUTOMATIC RADIOGRAPHIC | Mar 5, 1982 |
| K820305 | Tecnomed | RALCO COLLIMATORS, MANUAL RADIOGRAPHIC | Mar 4, 1982 |
| K820119 | Arrow X-Ray | PODIOSCOPE BY ARROW | Feb 18, 1982 |
| K811450 | Wedge Filtration System | ALUMINUM FILTRATION SYSTEM | Jul 2, 1981 |
| K791504 | Dial-X Instruments | AUTOMATIC POSITIVE BEAM COLLIMATOR | Sep 7, 1979 |
| K781984 | Siemens | COLLIMATOR, HEART CONTOUR | Dec 4, 1978 |
| K770335 | Litton Medical Systems | COLLIMATOR, AUTOMATIC | Feb 28, 1977 |