Jointvue, LLC
United StatesFDA applicant, unverified FDA FEI 3013535906
- Devices
- 5
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Jointvue, LLC makes
Jointvue, LLC manufactures software-based medical imaging tools, including a 3D echocardiography analysis platform and a surgical planning application for orthopedic procedures. The 3D Echo and its updated version (v1.1) process and visualize cardiac ultrasound data for diagnostic purposes, while the jFit Surgical Planner assists in preoperative planning for joint replacements by generating tailored surgical guides.
The company’s products are classified as Class II devices under FDA regulations and are listed via the 510(k) clearance pathway. These devices are intended for use in the United States, where Jointvue, LLC is based.
Catalogue
- Registry: GUDID
- Registry: GUDID
3D Echo Ref K172513
Regimes: 510(k) Registry: 510(k)jFit Surgical Planner Ref K173329
Regimes: 510(k) Registry: 510(k)3D Echo v1.1 Ref K211656
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3013535906
- DUNS number
- 117090348
- Address
- 2450 E.J. Chapman Drive, Knoxville, TN, 37996
- [email protected]
- Phone
- 8652351241
Frequently asked questions
How many devices does Jointvue, LLC have in the registry?
The registry currently lists 5 devices for Jointvue, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Jointvue, LLC's devices?
Among its 5 most recently registered devices, Jointvue, LLC has devices listed in FDA 510(k) (3 devices) and FDA GUDID (2 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Jointvue, LLC's devices fall under?
Among its 5 most recently registered devices, the classes recorded for Jointvue, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Jointvue, LLC in the registry?
The most recently registered devices listed for Jointvue, LLC include JointVue 3D Echo 1.0, JointVue jFit 1.0, 3D Echo and jFit Surgical Planner.