Product code IZX— Radiology
SHIMADZU COLLIMATOR R-20J
- Classification name
- Collimator, Manual, Radiographic
- Device class
- Class 2
- Regulation
- 21 CFR 892.1610
- Advisory panel
- Radiology
- Total cleared
- 17
- First cleared
- Most recent
Market context for product code IZX
FDA has cleared devices under product code IZX between 1977 and 2011, 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
last 15 years- 2011
- 2010
- 2004
- 2003
- 1998
- 1997
- 1993
- 1991
- 1990
- 1987
- 1986
- 1984
- 1980
- 1978
- 1977
Top applicants under product code IZX
Recent clearances under product code IZX
- K110856 — RALCO
- K101036 — SHIMADZU COLLIMATOR R-20J
- K042840 — SHIMADZU COLLIMATOR R-20J
- K031771 — SHIMADZU COLLIMATOR R-30H
- K981267 — FACTS MONOBLOCK
- K974240 — LIGHTLINE-M
- K972966 — AXT 150M MANUAL COLLIMATOR (AXT 150M)
- K932134 — RINN UNIVERSAL COLLIMATOR
- K912180 — MODEL MGB-301 DIAPHRAGM FILM 24 X 30 CM
- K900007 — R-100-ET MANUAL COLLIMATOR
- K896486 — R-150-ET COLLIMATOR
- K874687 — COLLI-MATETM MODEL NO. B800
- K861941 — COLLIMATOR MODEL A280BLMD & MODEL A280BLMP
- K840678 — UXM MODEL 8188
- K801168 — COLLIMAX X-RAY COLLIMATOR # R-182
- K780736 — CT 5221 DOSE REDUCING COLLIMATORS
- K771689 — DIAL X COLLIMATOR MODEL A&B
Data sourced from openFDA. This site is unofficial and independent of the FDA.