Almen Laboratories, Inc.
Country not established
- Devices
- 2
What Almen Laboratories, Inc. makes
Almen Laboratories, Inc. develops software tools designed to assist in the interpretation of breast imaging studies, including the BI-RADS Companion and the Breast Companion Software System. These tools are intended to support radiologists and healthcare providers in standardizing reporting and improving diagnostic accuracy for mammographic findings.
The company’s products are classified as Class II medical devices under FDA regulations and have undergone premarket approval (PMA) and 510(k) clearance processes. These devices are listed in the FDA’s regulatory databases, and the manufacturer is based in the United States.
Catalogue
Bi-Rads Companion Ref K072258
Regimes: 510(k) Registry: 510(k)Breast Companion Software System Ref P100007
Regimes: PMA, withdrawn Registry: PMA
Frequently asked questions
How many devices does Almen Laboratories, Inc. have in the registry?
The registry currently lists 2 devices for Almen Laboratories, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Almen Laboratories, Inc.'s devices?
Among its 2 most recently registered devices, Almen Laboratories, Inc. has devices listed in FDA 510(k) (1 device) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Almen Laboratories, Inc.'s devices fall under?
Among its 2 most recently registered devices, the classes recorded for Almen Laboratories, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Almen Laboratories, Inc. in the registry?
The most recently registered devices listed for Almen Laboratories, Inc. include BI-RADS COMPANION and BREAST COMPANION SOFTWARE SYSTEM.