Diagnosoft, Inc.
United StatesFDA applicant, unverified
- Devices
- 3
What Diagnosoft, Inc. makes
Diagnosoft, Inc. manufactures diagnostic ultrasound systems, including the VIRTUE platform and the DIAGNOSOFT HARP series (models 2.06 and earlier). These devices are designed for medical imaging, supporting applications such as obstetrics, gynecology, and general diagnostic ultrasound procedures.
The company’s products are classified as Class II medical devices under FDA regulations and are listed via 510(k) clearance. The portfolio is regulated in the United States, where the manufacturer is based.
Catalogue
Virtue Ref K111833
Regimes: 510(k) Registry: 510(k)Diagnosoft Harp Model 2.06 Ref K100352
Regimes: 510(k) Registry: 510(k)Diagnosoft Harp Ref K061368
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Diagnosoft, Inc. have in the registry?
The registry currently lists 3 devices for Diagnosoft, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Diagnosoft, Inc.'s devices?
Among its 3 most recently registered devices, Diagnosoft, Inc. has devices listed in FDA 510(k) (3 devices).
What risk classes do Diagnosoft, Inc.'s devices fall under?
Among its 3 most recently registered devices, the classes recorded for Diagnosoft, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Diagnosoft, Inc. in the registry?
The most recently registered devices listed for Diagnosoft, Inc. include VIRTUE, DIAGNOSOFT HARP MODEL 2.06 and DIAGNOSOFT HARP.