Infimed, Inc.
United StatesFDA 510(k) applicant, unverified
- Devices
- 27
What Infimed, Inc. makes
Infomed, Inc. manufactures digital X-ray imaging systems, including standalone models like the I5 Digital X-Ray Imaging System and the Orion Digital Imaging System, as well as specialized variants such as the Nexus DRF Digital X-Ray Imaging System. Their portfolio also includes dental imaging systems, cardiovascular workstations (e.g., Model CWS 5000/CWS 3000), and accessories like InfiStitch for the I5 system. Additional products include the QL Multipulse 2048, Theraview, and standalone systems like the Patriot and RTLX.
The company’s devices are classified under FDA regulations as Class I or Class II, with most requiring 510(k) clearance. These products are listed in the FDA’s 510(k) registry, reflecting their regulatory authorization status. Infomed, Inc. is headquartered in the United States.
Catalogue
Search and filter all 27 devicesCompany details
- DUNS number
- 197117211
Frequently asked questions
How many devices does INFIMED, INC. have in the registry?
The registry currently lists 27 devices for INFIMED, INC.. Devices recorded under merged duplicate company entries are counted once.
Which registries list INFIMED, INC.'s devices?
Among its 27 most recently registered devices, INFIMED, INC. has devices listed in FDA 510(k) (14 devices) and FDA GUDID (13 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do INFIMED, INC.'s devices fall under?
Among its 27 most recently registered devices, the classes recorded for INFIMED, INC.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from INFIMED, INC. in the registry?
The most recently registered devices listed for INFIMED, INC. include InfiMed Nexus, RF/DR, Non Varian Digital Receptor Nexus DRF (RF/DR), InfiMed Precision RXi, RF/DSA, CCD Camera Precision RXi D, InfiMed Nexus, DR, Digital Receptor Nexus DR and InfiMed Nexus, DRF, v2.5.