Product code KPW— Radiology
ALUMINUM FILTRATION SYSTEM
- Classification name
- Device, Beam Limiting, X-Ray, Diagnostic
- Device class
- Class 2
- Regulation
- 21 CFR 892.1610
- Advisory panel
- Radiology
- Total cleared
- 16
- First cleared
- Most recent
Market context for product code KPW
FDA has cleared devices under product code KPW between 1977 and 2010, filed by 14 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 2010
- 2006
- 2003
- 1995
- 1991
- 1990
- 1982
- 1981
- 1979
- 1978
- 1977
Top applicants under product code KPW
Recent clearances under product code KPW
- K093596 — LUMOS, MODEL R 72B
- K062788 — COLLIMATOR, MODEL M-38
- K030487 — R 72
- K954310 — BLA-800A
- K946320 — R 302
- K914184 — P2020-8-0 BEAM-LIMITING DEVICE
- K904587 — DENSICOMP 250
- K904044 — TF-63SA
- K904489 — EUREKA EXTENSION CYLINDERS
- K820306 — RALCO COLLIMATOR, AUTOMATIC RADIOGRAPHIC
- K820305 — RALCO COLLIMATORS, MANUAL RADIOGRAPHIC
- K820119 — PODIOSCOPE BY ARROW
- K811450 — ALUMINUM FILTRATION SYSTEM
- K791504 — AUTOMATIC POSITIVE BEAM COLLIMATOR
- K781984 — COLLIMATOR, HEART CONTOUR
- K770335 — COLLIMATOR, AUTOMATIC
Data sourced from openFDA. This site is unofficial and independent of the FDA.