Orex Computed Radiography, Ltd.
Country not established
- Devices
- 3
What Orex Computed Radiography, Ltd. makes
Orex Computed Radiography, Ltd. manufactures portable computed radiography (CR) cassettes and digital imaging devices for point-of-care X-ray imaging, including the PORT CASSETTE and the PCCR DIGITAL IMAGING DEVICE. Their product line also includes Kodak-branded point-of-care CR systems (CR 120, CR 140, CR 260), designed for mobile and bedside radiographic imaging in clinical settings.
These devices are classified as Class II under FDA regulations and are authorised via the 510(k) clearance process. The company is based in the United States, and its products are listed in the FDA’s 510(k) registry.
Catalogue
Port Cassette Ref K032654
Regimes: 510(k) Registry: 510(k)Pccr Digital Imaging Device Ref K003256
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Orex Computed Radiography, Ltd. have in the registry?
The registry currently lists 3 devices for Orex Computed Radiography, Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Orex Computed Radiography, Ltd.'s devices?
Among its 3 most recently registered devices, Orex Computed Radiography, Ltd. has devices listed in FDA 510(k) (3 devices).
What risk classes do Orex Computed Radiography, Ltd.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Orex Computed Radiography, Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Orex Computed Radiography, Ltd. in the registry?
The most recently registered devices listed for Orex Computed Radiography, Ltd. include PORT CASSETTE, PCCR DIGITAL IMAGING DEVICE and KODAK POINT OF CARE CR 120, KODAK POINT OF CARE CR 140, KODAK POINT OF CARE CR 260.