Data / Medical devices / Holder, Head, Radiographic
Holder, Head, Radiographic (IWY): 24 FDA-registered makers in 6 countries
24 establishments in 6 countries are registered with the FDA to make Holder, Head, Radiographic (product code IWY, Class 1, 21 CFR 892.1920). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 10 510(k) clearances under this code, the latest on December 28, 1992, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.
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- Product code
- IWY
- Device class
- 1
- Regulation
- 892.1920
- Medical specialty
- Radiology
Makers by country
| Country | Makers |
|---|---|
| United States | 13 |
| China | 4 |
| Israel | 3 |
| Germany | 2 |
| Taiwan | 1 |
| Switzerland | 1 |
Makers of Holder, Head, 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 |
|---|---|---|---|---|---|---|---|---|
| Anholt Technologies Inc. | Avondale, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beijing Health Medical Technology Co., Ltd | Beijing, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Blessing Cathay Corporation | New Taipei City, Taiwan | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Baxter Medical Systems GmbH + Co. KG | SAALFELD Thuringia, Germany | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Cassemco, Inc. | Cookeville, TN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Creative Foam Corporation - Bremen | Bremen, IN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dental Imaging Technologies Corporation | Quakertown, PA, United States | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Domico Med-Device, LLC | Fenton, MI, United States | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Medical Systems Israel, Functional Imaging | TIRAT HACARMEL Haifa, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Medical Systems Israel, Functional Imaging | Haifa, Israel | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Medical Systems Israel, Functional Imaging | Haifa, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Guangdong Meicen Medical Equipment Co., Ltd. | foshan Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hyperfine, Inc | Guilford, CT, United States | Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Klarity Medical & Equipment (GZ) Co., Ltd. | Guangzhou Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Klarity Medical Products, LLC | Heath, OH, United States | Contract manufacturer, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Maquet GMBH | RASTATT Baden-Wurttemberg, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Medtec LLC | Orange City, IA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Neocis Inc | Miami, FL, United States | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Pearl Technology AG | Schlieren Zurich, Switzerland | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Radiation Products Design, Inc. | Albertville, MN, United States | Manufacturer, Repackager or relabeler | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Tengfei Yu Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Standard Imaging, Inc. | Middleton, WI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Techno-Aide, Inc. | Whites Creek, TN, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Xoran Technologies, LLC | Ann Arbor, MI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated December 28, 1992. 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.