Advanced Mammography Systems, Inc.
Country not established
- Devices
- 1
What Advanced Mammography Systems, Inc. makes
Advanced Mammography Systems, Inc. manufactures the Aurora Imaging System, a device designed for digital mammography used in breast cancer screening and diagnosis. This system provides high-resolution imaging to support early detection of abnormalities in breast tissue, including microcalcifications and masses.
The company’s portfolio is regulated under Class II medical devices in the United States, with the Aurora Imaging System authorised through the FDA’s 510(k) clearance process. The device is listed in the FDA’s 510(k) database, adhering to U.S. regulatory requirements for mammography equipment.
Catalogue
Aurora Imaging System Ref K950837
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Advanced Mammography Systems, Inc. have in the registry?
The registry currently lists 1 device for Advanced Mammography Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Advanced Mammography Systems, Inc.'s devices?
Among its 1 most recently registered device, Advanced Mammography Systems, Inc. has devices listed in FDA 510(k) (1 device).
What risk classes do Advanced Mammography Systems, Inc.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Advanced Mammography Systems, Inc.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Advanced Mammography Systems, Inc. in the registry?
The most recently registered devices listed for Advanced Mammography Systems, Inc. include AURORA IMAGING SYSTEM.