Envisioneering, LLC
United StatesFDA applicant, unverified
- Devices
- 4
What Envisioneering, LLC makes
Envisioneering, LLC manufactures transrectal ultrasound systems and biopsy kits, including needle guides designed for targeted prostate interventions. These systems integrate imaging and procedural tools to assist in precise tissue sampling and diagnostic procedures.
The company’s products are classified as Class II medical devices under FDA regulations and are supported by 510(k) clearances. The portfolio is listed in the FDA’s 510(k) database, reflecting compliance with U.S. device authorisation requirements.
Catalogue
Targetscn Transrectal Ultrasound System Ref K041639
Regimes: 510(k) Registry: 510(k)Targetscan Transrectal Ultrasound System Ref K041637
Regimes: 510(k) Registry: 510(k)Targetscan Biopsy Kit Ref K041638
Regimes: 510(k) Registry: 510(k)- Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Envisioneering, LLC have in the registry?
The registry currently lists 4 devices for Envisioneering, LLC. Devices recorded under merged duplicate company entries are counted once.
Which registries list Envisioneering, LLC's devices?
Among its 4 most recently registered devices, Envisioneering, LLC has devices listed in FDA 510(k) (4 devices).
What risk classes do Envisioneering, LLC's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Envisioneering, LLC's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Envisioneering, LLC in the registry?
The most recently registered devices listed for Envisioneering, LLC include TARGETSCN TRANSRECTAL ULTRASOUND SYSTEM, TARGETSCAN TRANSRECTAL ULTRASOUND SYSTEM, TARGETSCAN BIOPSY KIT and TARGETSCAN BIOPSY KIT, TARGETSCAN BIOPSY NEEDLE GUIDE.