IZW · Collimator, Automatic, Radiographic
Radiology · 21 CFR 892.1610 · Class 2
Overview
| Product Code | IZW |
|---|---|
| Device Name | Collimator, Automatic, Radiographic |
| Regulation | 21 CFR 892.1610 |
| Device Class | Class 2 |
| Review Panel | Radiology |
Identification
A diagnostic x-ray beam-limiting device is a device such as a collimator, a cone, or an aperture intended to restrict the dimensions of a diagnostic x-ray field by limiting the size of the primary x-ray beam.
Classification Rationale
Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Special Controls
*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Recent Cleared Devices (20 of 23)
Showing 20 most recent of 23 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K101039 | SHIMADZU COLLIMATOR R-300 | Shimadzu Corp. | Sep 20, 2010 | SESE |
| K093572 | R650 QDASM COLLIMATOR | Omega Medical Imaging, Inc. | Feb 3, 2010 | SESE |
| K090578 | SHIMADZU COLLIMATOR R-30H | Shimadzu Corp. | Nov 6, 2009 | SESE |
| K091517 | RALCO, MODEL R225 ACS | Ralco S.R.L. | Jul 14, 2009 | SESE |
| K083029 | MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR | Ralco S.R.L. | Dec 5, 2008 | SESE |
| K072780 | MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR | Ralco S.R.L. | Nov 26, 2007 | SESE |
| K073124 | COLLIMARE COLLIMATOR FAMILY | Collimare, LLC | Nov 16, 2007 | SESE |
| K050092 | R605 FACS COLLIMETER | Omega Medical Imaging, Inc. | Jan 31, 2005 | SESE |
| K031597 | DUNLEE FORMAT COLLIMATOR FAMILY | Philips Medical Systems North America Co. | Jul 21, 2003 | SESE |
| K990423 | PHILIPS NICOL COLLIMATOR FAMILY | Philips Medical Systems, Inc. | Mar 15, 1999 | SESE |
| K984414 | XRE COLLIMATOR WITH SPECTRAL FILTER | Trex Medical Corp. | Dec 30, 1998 | SESE |
| K960998 | XRE COLLIMATOR | Xre Corp. | Apr 3, 1996 | SESE |
| K951372 | PHILIPS GALLILEO AUTOMATIC COLLIMATOR (OR BEAM LIMITING DEVICE) | Philips Medical Systems, Inc. | May 4, 1995 | SESE |
| K920733 | STEREO COLLIMATOR RF-T SERIES | Shimadzu Medical Systems | Apr 16, 1992 | SESE |
| K920725 | COLLIMATOR F-20 | Shimadzu Medical Systems | Apr 16, 1992 | SESE |
| K911127 | COLLIMASTER-90 | Varian Assoc., Inc. | Sep 19, 1991 | SESE |
| K894142 | ULTRANET-S COLLIMATOR | GE Medical Systems | Nov 6, 1989 | SESE |
| K861942 | COLLIMATOR MODEL A280BLE & MODEL A280-BLM | D&R X-Ray Products, Inc. | Jul 25, 1986 | SESE |
| K862340 | SENTEC LASER GUIDE LINE, MODEL SGL-05 | Sentec Corp. | Jul 11, 1986 | SESE |
| K843244 | LIGHT BEAM COLLIMATOR | Dealers X-Ray Co., Inc. | Sep 14, 1984 | SESE |
Top Applicants
- Ralco S.R.L. — 3 clearances
- Shimadzu Medical Systems — 2 clearances
- Shimadzu Corp. — 2 clearances
- Philips Medical Systems, Inc. — 2 clearances
- Omega Medical Imaging, Inc. — 2 clearances
