Product code IZW— Radiology
COLLIMARE COLLIMATOR FAMILY
- Classification name
- Collimator, Automatic, Radiographic
- Device class
- Class 2
- Regulation
- 21 CFR 892.1610
- Advisory panel
- Radiology
- Total cleared
- 23
- First cleared
- Most recent
Market context for product code IZW
FDA has cleared devices under product code IZW between 1981 and 2010, filed by 17 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- 2010
- 2009
- 2008
- 2007
- 2005
- 2003
- 1999
- 1998
- 1996
- 1995
- 1992
- 1991
- 1989
- 1986
- 1984
Top applicants under product code IZW
Recent clearances under product code IZW
- K101039 — SHIMADZU COLLIMATOR R-300
- K093572 — R650 QDASM COLLIMATOR
- K090578 — SHIMADZU COLLIMATOR R-30H
- K091517 — RALCO, MODEL R225 ACS
- K083029 — MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR
- K072780 — MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR
- K073124 — COLLIMARE COLLIMATOR FAMILY
- K050092 — R605 FACS COLLIMETER
- K031597 — DUNLEE FORMAT COLLIMATOR FAMILY
- K990423 — PHILIPS NICOL COLLIMATOR FAMILY
- K984414 — XRE COLLIMATOR WITH SPECTRAL FILTER
- K960998 — XRE COLLIMATOR
- K951372 — PHILIPS GALLILEO AUTOMATIC COLLIMATOR (OR BEAM LIMITING DEVICE)
- K920725 — COLLIMATOR F-20
- K920733 — STEREO COLLIMATOR RF-T SERIES
- K911127 — COLLIMASTER-90
- K894142 — ULTRANET-S COLLIMATOR
- K861942 — COLLIMATOR MODEL A280BLE & MODEL A280-BLM
- K862340 — SENTEC LASER GUIDE LINE, MODEL SGL-05
- K843244 — LIGHT BEAM COLLIMATOR
- K833779 — YTTRO FILTER
- K810590 — P.R.M. 80
- K810598 — X-RAY COLLIMATING DEVICES
Data sourced from openFDA. This site is unofficial and independent of the FDA.