KPW
16 FDA 510(k) clearances · Product code
41 daysmedian time to decision
134 days90th percentile
16clearances measured
FDA profile
- Official device name
- Device, Beam Limiting, X-Ray, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.1610
- Medical specialty
- Radiology
- Adverse events (MAUDE)
- 1996: 2 · 1997: 2
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| LUMOS, MODEL R 72B (K093596) | Lumos, Inc. | 2010-01-12 |
| COLLIMATOR, MODEL M-38 (K062788) | Umi International | 2006-12-28 |
| R 72 (K030487) | Ralco S.R.L. | 2003-08-01 |
| BLA-800A (K954310) | Toshiba Medical Systems | 1995-10-18 |
| R 302 (K946320) | Ralco S.R.L. | 1995-05-11 |
| P2020-8-0 BEAM-LIMITING DEVICE (K914184) | Precise Optics | 1991-11-27 |
| DENSICOMP 250 (K904587) | L. Keroack Co. | 1991-01-24 |
| TF-63SA (K904044) | Toshiba America Medical Systems, In.C | 1990-11-29 |
| EUREKA EXTENSION CYLINDERS (K904489) | Eureka X-Ray Tube Corp. | 1990-10-15 |
| RALCO COLLIMATOR, AUTOMATIC RADIOGRAPHIC (K820306) | Tecnomed, Inc. | 1982-03-05 |
| RALCO COLLIMATORS, MANUAL RADIOGRAPHIC (K820305) | Tecnomed, Inc. | 1982-03-04 |
| PODIOSCOPE BY ARROW (K820119) | Arrow X-Ray Corp. | 1982-02-18 |
| ALUMINUM FILTRATION SYSTEM (K811450) | Wedge Filtration System | 1981-07-02 |
| AUTOMATIC POSITIVE BEAM COLLIMATOR (K791504) | Dial-X Instruments, Inc. | 1979-09-07 |
| COLLIMATOR, HEART CONTOUR (K781984) | Siemens Corp. | 1978-12-04 |
| COLLIMATOR, AUTOMATIC (K770335) | Litton Medical Systems | 1977-02-28 |
Track KPW automatically
Every clearance here is in the API, with alerts when new ones post.