Data / Medical devices / Collimator, Automatic, Radiographic
Collimator, Automatic, Radiographic (IZW): 13 FDA-registered makers in 6 countries
13 establishments in 6 countries are registered with the FDA to make Collimator, Automatic, Radiographic (product code IZW, Class 2, 21 CFR 892.1610). 4 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 23 510(k) clearances under this code, the latest on September 20, 2010, and lists 3 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- IZW
- Device class
- 2
- Regulation
- 892.1610
- Medical specialty
- Radiology
Makers by country
| Country | Makers |
|---|---|
| China | 5 |
| United States | 3 |
| Netherlands | 2 |
| Italy | 1 |
| Japan | 1 |
| Mexico | 1 |
Makers of Collimator, Automatic, Radiographic
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Ralco S.R.L. | Biassono Monza e Brianza, Italy | Contract manufacturer, Manufacturer | 3 | July 14, 2009 | 0 | 0 | 0 | api.fda.gov |
| Shimadzu Corporation Medical Systems Division | Kyoto, Japan | Manufacturer | 3 | September 20, 2010 | 0 | 0 | 0 | api.fda.gov |
| Collimare, LLC | Golden, CO, United States | Manufacturer | 1 | November 16, 2007 | 0 | 0 | 0 | api.fda.gov |
| Philips Medical Systems Nederland B.V. | BEST Noord-Brabant, Netherlands | Complaint file establishment, Specification developer | 1 | July 21, 2003 | 0 | 0 | 0 | api.fda.gov |
| Fairy Medical Electrics(jiaxing)co.,ltd | Jiaxing Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Hangwei Medical Systems Co., Ltd. | Beijing, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Healthcare (China) Co., Ltd. | Beijing, China | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Medical Systems Monterrey Mexico, S.A. De C.V. | APODACA Nuevo Leon, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Medical Systems, LLC | Waukesha, WI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Medical Systems Ultrasound & Primary Care Diagnostics LLC | Madison, WI, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips Medical Systems Nederland B.V. | BEST Noord-Brabant, Netherlands | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Suzhou Shangchuang Technology Service Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| iRay Imaging Technology (Haining) Limited | Haining Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 20, 2010. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.