Collimator, Manual, Radiographic
A manual radiographic collimator is a beam-limiting device operated by hand to adjust the size and shape of the X-ray beam before exposure, reducing scatter radiation and improving radiographic image quality. It is classified as FDA Class 2, reflecting moderate risk and a 510(k) premarket notification requirement. The product code is IZX, regulated under 21 CFR 892.1610, within the Radiology medical specialty. No special flags apply to this device.
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Basic Information
- Product Code
- IZX
- Device Class
- FDA class 2
- Regulation Number
- 892.1610
- Medical Specialty
- Radiology
- Review Panel
- RA
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 17 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K110856 | RALCO | Aug 10, 2011 | Substantially Equivalent | Ralco S.R.L. |
| K101036 | SHIMADZU COLLIMATOR R-20J | Aug 26, 2010 | Substantially Equivalent | Shimadzu Corp. |
| K042840 | SHIMADZU COLLIMATOR R-20J | Dec 03, 2004 | Substantially Equivalent | Shimadzu Corp. |
| K031771 | SHIMADZU COLLIMATOR R-30H | Aug 21, 2003 | Substantially Equivalent | Shimadzu Corp. |
| K981267 | FACTS MONOBLOCK | May 06, 1998 | Substantially Equivalent | Dynarad Corp. |
| K974240 | LIGHTLINE-M | Dec 22, 1997 | Substantially Equivalent | Wuestec Medical, Inc. |
| K972966 | AXT 150M MANUAL COLLIMATOR (AXT 150M) | Aug 21, 1997 | Substantially Equivalent | Applied X-Ray Technologies, Inc. |
| K932134 | RINN UNIVERSAL COLLIMATOR | Jul 26, 1993 | Substantially Equivalent | Rinn Corp. |
| K912180 | MODEL MGB-301 DIAPHRAGM FILM 24 X 30 CM | Oct 21, 1991 | Substantially Equivalent | Instrumentarium Imaging, Inc. |
| K900007 | R-100-ET MANUAL COLLIMATOR | Feb 06, 1990 | Substantially Equivalent | Advantech |
| K896486 | R-150-ET COLLIMATOR | Jan 23, 1990 | Substantially Equivalent | Advantech |
| K874687 | COLLI-MATETM MODEL NO. B800 | Dec 30, 1987 | Substantially Equivalent | Summit Industries, Inc. |
| K861941 | COLLIMATOR MODEL A280BLMD & MODEL A280BLMP | Jul 25, 1986 | Substantially Equivalent | D&R X-Ray Products, Inc. |
| K840678 | UXM MODEL 8188 | Mar 16, 1984 | Substantially Equivalent | Universal X-Ray |
| K801168 | COLLIMAX X-RAY COLLIMATOR # R-182 | Jul 08, 1980 | Substantially Equivalent | Ito X-Ray Corp. |
| K780736 | CT 5221 DOSE REDUCING COLLIMATORS | Jun 02, 1978 | Substantially Equivalent | Emi Medical, Inc. |
| K771689 | DIAL X COLLIMATOR MODEL A&B | Sep 14, 1977 | Substantially Equivalent | Bennett X-Ray Corp. |
FEI Numbers
This FDA classification entry is associated with 14 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 14 registration numbers. Click on an entry to view related FDA registrations.