Digivision, Inc.
United StatesFDA applicant, unverified
- Devices
- 4
What Digivision, Inc. makes
Digivision, Inc. manufactures medical imaging devices designed to enhance video and fluoroscopic contrast, including real-time video contrast enhancers and high-resolution image enhancement systems. Their portfolio includes standalone contrast enhancers and integrated solutions like the Digiviewer, which processes fluoroscopic images for improved visibility. These devices are primarily used in procedural and diagnostic imaging to reduce radiation exposure and improve clinician workflow.
The company’s devices are classified as Class II under FDA regulations and are supported by 510(k) clearances. Their products are listed in the FDA’s 510(k) database, adhering to U.S. medical device compliance requirements. Digivision, Inc. is headquartered in the United States.
Catalogue
Real-Time Video Contrast Enhancer Ref K962260
Regimes: 510(k) Registry: 510(k)Digiviewer Ref K873646
Regimes: 510(k) Registry: 510(k)Fluorovision Contrast Enhancer Ref K864584
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Digivision, Inc. have in the registry?
The registry currently lists 4 devices for Digivision, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Digivision, Inc.'s devices?
Among its 4 most recently registered devices, Digivision, Inc. has devices listed in FDA 510(k) (4 devices).
What risk classes do Digivision, Inc.'s devices fall under?
Among its 4 most recently registered devices, the classes recorded for Digivision, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Digivision, Inc. in the registry?
The most recently registered devices listed for Digivision, Inc. include REAL-TIME VIDEO CONTRAST ENHANCER, DIGIVIEWER, FLUOROVISION CONTRAST ENHANCER and FLUOROVISION HR 2000 HIGH RESOLUTION IMAGE ENHANCE.