Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1610](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1610) → IZX — Collimator, Manual, Radiographic # IZX · Collimator, Manual, Radiographic _Radiology · 21 CFR 892.1610 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZX ## Overview - **Product Code:** IZX - **Device Name:** Collimator, Manual, Radiographic - **Regulation:** [21 CFR 892.1610](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1610) - **Device Class:** 2 - **Review Panel:** [Radiology](/submissions/RA) ## 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](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZX/K110856.md) | RALCO | Ralco S.R.L. | Aug 10, 2011 | SESE | | [K101036](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZX/K101036.md) | SHIMADZU COLLIMATOR R-20J | Shimadzu Corp. | Aug 26, 2010 | SESE | | [K042840](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZX/K042840.md) | SHIMADZU COLLIMATOR R-20J | Shimadzu Corp. | Dec 3, 2004 | SESE | | [K031771](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZX/K031771.md) | SHIMADZU COLLIMATOR R-30H | Shimadzu Corp. | Aug 21, 2003 | SESE | | [K981267](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZX/K981267.md) | FACTS MONOBLOCK | Dynarad Corp. | May 6, 1998 | SESE | | [K974240](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZX/K974240.md) | LIGHTLINE-M | Wuestec Medical, Inc. | Dec 22, 1997 | SESE | | [K972966](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZX/K972966.md) | AXT 150M MANUAL COLLIMATOR (AXT 150M) | Applied X-Ray Technologies, Inc. | Aug 21, 1997 | SESE | | [K932134](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZX/K932134.md) | RINN UNIVERSAL COLLIMATOR | Rinn Corp. | Jul 26, 1993 | SESE | | [K912180](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZX/K912180.md) | MODEL MGB-301 DIAPHRAGM FILM 24 X 30 CM | Instrumentarium Imaging, Inc. | Oct 21, 1991 | SESE | | [K900007](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZX/K900007.md) | R-100-ET MANUAL COLLIMATOR | Advantech | Feb 6, 1990 | SESE | | [K896486](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZX/K896486.md) | R-150-ET COLLIMATOR | Advantech | Jan 23, 1990 | SESE | | [K874687](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZX/K874687.md) | COLLI-MATETM MODEL NO. B800 | Summit Industries, Inc. | Dec 30, 1987 | SESE | | [K861941](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZX/K861941.md) | COLLIMATOR MODEL A280BLMD & MODEL A280BLMP | D&R X-Ray Products, Inc. | Jul 25, 1986 | SESE | | [K840678](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZX/K840678.md) | UXM MODEL 8188 | Universal X-Ray | Mar 16, 1984 | SESE | | [K801168](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZX/K801168.md) | COLLIMAX X-RAY COLLIMATOR # R-182 | Ito X-Ray Corp. | Jul 8, 1980 | SESE | | [K780736](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZX/K780736.md) | CT 5221 DOSE REDUCING COLLIMATORS | Emi Medical, Inc. | Jun 2, 1978 | SESE | | [K771689](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZX/K771689.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZX](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZX) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com