IZX · Collimator, Manual, Radiographic
Radiology · 21 CFR 892.1610 · Class 2
Overview
| Product Code | IZX |
|---|---|
| Device Name | Collimator, Manual, 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 (17 of 17)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K110856 | RALCO | Ralco S.R.L. | Aug 10, 2011 | SESE |
| K101036 | SHIMADZU COLLIMATOR R-20J | Shimadzu Corp. | Aug 26, 2010 | SESE |
| K042840 | SHIMADZU COLLIMATOR R-20J | Shimadzu Corp. | Dec 3, 2004 | SESE |
| K031771 | SHIMADZU COLLIMATOR R-30H | Shimadzu Corp. | Aug 21, 2003 | SESE |
| K981267 | FACTS MONOBLOCK | Dynarad Corp. | May 6, 1998 | SESE |
| K974240 | LIGHTLINE-M | Wuestec Medical, Inc. | Dec 22, 1997 | SESE |
| K972966 | AXT 150M MANUAL COLLIMATOR (AXT 150M) | Applied X-Ray Technologies, Inc. | Aug 21, 1997 | SESE |
| K932134 | RINN UNIVERSAL COLLIMATOR | Rinn Corp. | Jul 26, 1993 | SESE |
| K912180 | MODEL MGB-301 DIAPHRAGM FILM 24 X 30 CM | Instrumentarium Imaging, Inc. | Oct 21, 1991 | SESE |
| K900007 | R-100-ET MANUAL COLLIMATOR | Advantech | Feb 6, 1990 | SESE |
| K896486 | R-150-ET COLLIMATOR | Advantech | Jan 23, 1990 | SESE |
| K874687 | COLLI-MATETM MODEL NO. B800 | Summit Industries, Inc. | Dec 30, 1987 | SESE |
| K861941 | COLLIMATOR MODEL A280BLMD & MODEL A280BLMP | D&R X-Ray Products, Inc. | Jul 25, 1986 | SESE |
| K840678 | UXM MODEL 8188 | Universal X-Ray | Mar 16, 1984 | SESE |
| K801168 | COLLIMAX X-RAY COLLIMATOR # R-182 | Ito X-Ray Corp. | Jul 8, 1980 | SESE |
| K780736 | CT 5221 DOSE REDUCING COLLIMATORS | Emi Medical, Inc. | Jun 2, 1978 | SESE |
| K771689 | DIAL X COLLIMATOR MODEL A&B | Bennett X-Ray Corp. | Sep 14, 1977 | SESE |
Top Applicants
- Shimadzu Corp. — 3 clearances
- Advantech — 2 clearances
- Applied X-Ray Technologies, Inc. — 1 clearance
- Bennett X-Ray Corp. — 1 clearance
- D&R X-Ray Products, Inc. — 1 clearance
