Radionics Medical, Inc.
Country not established
- Devices
- 5
What Radionics Medical, Inc. makes
Radionics Medical, Inc. manufactures ocular imaging and diagnostic devices, including the Ocular Biometer 4000 for intraocular lens power calculations, the SinusVu 2500 for sinus cavity imaging, and the CorneoMap 4500 for corneal topography and ultrasound measurements. The Spectrum Analyzer 8000 provides spectral analysis for ocular diagnostics. These tools support preoperative planning, surgical guidance, and postoperative assessment in ophthalmology.
The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. All products are based in the United States and comply with U.S. medical device authorization requirements.
Catalogue
Ocular Biometer 4000 Ref K827035
Regimes: 510(k) Registry: 510(k)Sinusvu 2500 Ref K833222
Regimes: 510(k) Registry: 510(k)Corneomap 4500 Ref K844299
Regimes: 510(k) Registry: 510(k)Spectrum Analyzer 8000 Ref K810851
Regimes: 510(k) Registry: 510(k)Corneomap 4500 Ultrasound Measurement Ref K837331
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Radionics Medical, Inc. have in the registry?
The registry currently lists 5 devices for Radionics Medical, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Radionics Medical, Inc.'s devices?
Among its 5 most recently registered devices, Radionics Medical, Inc. has devices listed in FDA 510(k) (5 devices).
What risk classes do Radionics Medical, Inc.'s devices fall under?
Among its 5 most recently registered devices, the classes recorded for Radionics Medical, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Radionics Medical, Inc. in the registry?
The most recently registered devices listed for Radionics Medical, Inc. include OCULAR BIOMETER 4000, SINUSVU 2500, CORNEOMAP 4500 and SPECTRUM ANALYZER 8000.