Cardiac Mariners, Inc.
United StatesFDA applicant, unverified
- Devices
- 2
What Cardiac Mariners, Inc. makes
Cardiac Mariners, Inc. manufactures the VASCO Scanning Beam Digital X-Ray System, a fixed imaging device for radiographic procedures, and the SBDX Mobile Fluoroscopy System, a portable fluoroscopy unit for real-time X-ray imaging.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company is based in the United States.
Catalogue
Vasco Scanning Beam Digital X-Ray System Ref K982345
Regimes: 510(k) Registry: 510(k)Sbdx Mobile Fluoroscopy System Ref K953113
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Cardiac Mariners, Inc. have in the registry?
The registry currently lists 2 devices for Cardiac Mariners, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Cardiac Mariners, Inc.'s devices?
Among its 2 most recently registered devices, Cardiac Mariners, Inc. has devices listed in FDA 510(k) (2 devices).
What risk classes do Cardiac Mariners, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Cardiac Mariners, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Cardiac Mariners, Inc. in the registry?
The most recently registered devices listed for Cardiac Mariners, Inc. include VASCO SCANNING BEAM DIGITAL X-RAY SYSTEM and SBDX MOBILE FLUOROSCOPY SYSTEM.