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) → IZW — Collimator, Automatic, Radiographic # IZW · Collimator, Automatic, Radiographic _Radiology · 21 CFR 892.1610 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZW ## Overview - **Product Code:** IZW - **Device Name:** Collimator, Automatic, 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 (20 of 23) Showing 20 most recent of 23 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K101039](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZW/K101039.md) | SHIMADZU COLLIMATOR R-300 | Shimadzu Corp. | Sep 20, 2010 | SESE | | [K093572](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZW/K093572.md) | R650 QDASM COLLIMATOR | Omega Medical Imaging, Inc. | Feb 3, 2010 | SESE | | [K090578](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZW/K090578.md) | SHIMADZU COLLIMATOR R-30H | Shimadzu Corp. | Nov 6, 2009 | SESE | | [K091517](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZW/K091517.md) | RALCO, MODEL R225 ACS | Ralco S.R.L. | Jul 14, 2009 | SESE | | [K083029](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZW/K083029.md) | MODEL R605DASM AUTOMATIC X-RAY COLLIMATOR | Ralco S.R.L. | Dec 5, 2008 | SESE | | [K072780](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZW/K072780.md) | MODEL R302DACS/A AUTOMATIC X-RAY COLLIMATOR | Ralco S.R.L. | Nov 26, 2007 | SESE | | [K073124](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZW/K073124.md) | COLLIMARE COLLIMATOR FAMILY | Collimare, LLC | Nov 16, 2007 | SESE | | [K050092](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZW/K050092.md) | R605 FACS COLLIMETER | Omega Medical Imaging, Inc. | Jan 31, 2005 | SESE | | [K031597](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZW/K031597.md) | DUNLEE FORMAT COLLIMATOR FAMILY | Philips Medical Systems North America Co. | Jul 21, 2003 | SESE | | [K990423](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZW/K990423.md) | PHILIPS NICOL COLLIMATOR FAMILY | Philips Medical Systems, Inc. | Mar 15, 1999 | SESE | | [K984414](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZW/K984414.md) | XRE COLLIMATOR WITH SPECTRAL FILTER | Trex Medical Corp. | Dec 30, 1998 | SESE | | [K960998](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZW/K960998.md) | XRE COLLIMATOR | Xre Corp. | Apr 3, 1996 | SESE | | [K951372](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZW/K951372.md) | PHILIPS GALLILEO AUTOMATIC COLLIMATOR (OR BEAM LIMITING DEVICE) | Philips Medical Systems, Inc. | May 4, 1995 | SESE | | [K920733](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZW/K920733.md) | STEREO COLLIMATOR RF-T SERIES | Shimadzu Medical Systems | Apr 16, 1992 | SESE | | [K920725](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZW/K920725.md) | COLLIMATOR F-20 | Shimadzu Medical Systems | Apr 16, 1992 | SESE | | [K911127](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZW/K911127.md) | COLLIMASTER-90 | Varian Assoc., Inc. | Sep 19, 1991 | SESE | | [K894142](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZW/K894142.md) | ULTRANET-S COLLIMATOR | GE Medical Systems | Nov 6, 1989 | SESE | | [K861942](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZW/K861942.md) | COLLIMATOR MODEL A280BLE & MODEL A280-BLM | D&R X-Ray Products, Inc. | Jul 25, 1986 | SESE | | [K862340](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZW/K862340.md) | SENTEC LASER GUIDE LINE, MODEL SGL-05 | Sentec Corp. | Jul 11, 1986 | SESE | | [K843244](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZW/K843244.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZW](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZW) **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