Data / Medical devices / Monitor, Patient Position, Light-Beam
Monitor, Patient Position, Light-Beam (IWE): 13 FDA-registered makers in 6 countries
13 establishments in 6 countries are registered with the FDA to make Monitor, Patient Position, Light-Beam (product code IWE, Class 1, 21 CFR 892.5780). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 28 510(k) clearances under this code, the latest on September 11, 2015, and lists 8 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- IWE
- Device class
- 1
- Regulation
- 892.5780
- Medical specialty
- Radiology
Makers by country
| Country | Makers |
|---|---|
| China | 5 |
| United States | 4 |
| Taiwan | 1 |
| Sweden | 1 |
| Finland | 1 |
| Germany | 1 |
Makers of Monitor, Patient Position, Light-Beam
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 |
|---|---|---|---|---|---|---|---|---|
| Aadco Medical, Inc. | Randolph, VT, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Aktina Medical Corp. | Congers, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amcad Biomed Corporation | Taipei, Taiwan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| C-Rad Positioning AB | Uppsala, Sweden | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Oec Medical Systems, Inc | Salt Lake City, UT, United States | 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 | |
| Huestis Machine Corp. | Bristol, RI, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Infitek Co., Ltd. | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Innokas Medical OY | KEMPELE Pohjois-Pohjanmaa, Finland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Labpeak Co.,ltd | Jinan Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Lap GMBH Laser Applikationen | LUENEBURG Lower Saxony, Germany | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Scitek Global Co.,ltd | Jinan Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Tengfei Yu Technology Co., Ltd. | Shenzhen Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated September 11, 2015. 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.