Data / Medical devices / Collimator, Manual, Radiographic
Collimator, Manual, Radiographic (IZX): 11 FDA-registered makers in 6 countries
11 establishments in 6 countries are registered with the FDA to make Collimator, Manual, Radiographic (product code IZX, 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 17 510(k) clearances under this code, the latest on August 10, 2011, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- IZX
- Device class
- 2
- Regulation
- 892.1610
- Medical specialty
- Radiology
Makers by country
| Country | Makers |
|---|---|
| United States | 3 |
| South Korea | 2 |
| China | 2 |
| Netherlands | 2 |
| Italy | 1 |
| Japan | 1 |
Makers of Collimator, Manual, 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 |
|---|---|---|---|---|---|---|---|---|
| Dentsply LLC | York, PA, United States | Manufacturer | 1 | July 26, 1993 | 0 | 0 | 0 | api.fda.gov |
| Huestis Machine Corp. | Bristol, RI, United States | Manufacturer | 1 | August 21, 1997 | 0 | 0 | 0 | api.fda.gov |
| Ralco S.R.L. | Biassono Monza e Brianza, Italy | Manufacturer | 1 | August 10, 2011 | 0 | 0 | 0 | api.fda.gov |
| Shimadzu Corporation Medical Systems Division | Kyoto, Japan | Manufacturer | 1 | August 26, 2010 | 0 | 0 | 0 | api.fda.gov |
| Collimare, LLC | Golden, CO, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Drgem Corporation | Gwangmyeong-si Gyeongbuk, South Korea | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DRGEM Corporation (Gimcheon Factory) | Gimcheon-si Gyeongbuk, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Fairy Medical Electrics(jiaxing)co.,ltd | Jiaxing Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips Medical Systems Nederland B.V. | BEST Noord-Brabant, Netherlands | Complaint file establishment, 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 | |
| iRay Imaging Technology (Haining) Limited | Haining Zhejiang, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated August 10, 2011. 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.