Visidyne Corp.
United StatesFDA applicant, unverified
- Devices
- 3
What Visidyne Corp. makes
Visidyne Corp. manufactures electrophysiology systems, including the PANTOS M-2 for diagnostic testing of visual pathways, and portable ultrasound scanners like the TRISCAN models (38, 40, 41, 43, 45) for ophthalmic and general imaging. The company also produces the CHROMOPS FM-100, a device for assessing color vision in clinical settings.
The company’s portfolio includes Class I and Class II devices, with submissions recorded in the FDA’s 510(k) registry. These products are intended for use in the United States, where the manufacturer is based.
Catalogue
Pantops M-2 Electrophysiology System Ref K810699
Regimes: 510(k) Registry: 510(k)Triscan, Models 38, 40, 41, 43 & 45 Ref K811316
Regimes: 510(k) Registry: 510(k)Chromops Fm-100 Color Vision Tester Ref K810700
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Visidyne Corp. have in the registry?
The registry currently lists 3 devices for Visidyne Corp.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Visidyne Corp.'s devices?
Among its 3 most recently registered devices, Visidyne Corp. has devices listed in FDA 510(k) (3 devices).
What risk classes do Visidyne Corp.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Visidyne Corp.'s devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Visidyne Corp. in the registry?
The most recently registered devices listed for Visidyne Corp. include PANTOPS M-2 ELECTROPHYSIOLOGY SYSTEM, TRISCAN, MODELS 38, 40, 41, 43 & 45 and CHROMOPS FM-100 COLOR VISION TESTER.