Adani
BY Last updated 22 Oct 2026
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- Devices
- 2
- Registries
- FDA 510(k)
- FDA recalls
- 0
Catalogue
Uniexpert 2 Plus Ref K200944
Adani MammoScan Ref K172027
What Adani makes
The company manufactures digital mammography systems, including the UNIEXPERT 2 PLUS and the Adani MammoScan, which are designed for breast imaging in clinical settings. These devices are intended for screening and diagnostic evaluations to detect abnormalities such as tumors or calcifications in breast tissue.
The portfolio consists of Class II medical devices, all of which are listed via the FDA’s 510(k) premarket notification process. These products are registered under U.S. regulatory authorities and are based in the United States.
Frequently asked questions
What types of medical devices does Adani manufacture?
Adani specializes in digital mammography systems, including the UNIEXPERT 2 PLUS and the Adani MammoScan. These devices are specifically designed for breast imaging in clinical environments, enabling screening and diagnostic evaluations to identify abnormalities such as tumors or calcifications in breast tissue.
Where is Adani based, and what regulatory framework governs its devices?
Adani is based in the United States. Its devices fall under U.S. regulatory oversight, specifically the FDA’s 510(k) premarket notification process, which is used to demonstrate that a device is substantially equivalent to a legally marketed predicate device. This process applies to all of Adani’s Class II medical devices.
Which regulatory registries or databases list Adani’s devices?
Adani’s devices are listed in the FDA’s 510(k) registry. This registry tracks devices that have undergone the 510(k) premarket notification process, ensuring they meet regulatory requirements for safety and effectiveness before commercial distribution in the U.S.
How are Adani’s devices classified under medical device regulations?
Adani’s devices are classified as Class II medical devices. This classification is determined by the FDA based on the level of risk associated with the device. Class II devices generally require special controls in addition to general controls to ensure their safety and performance, and they are subject to the 510(k) process to demonstrate equivalence to a predicate device.
Information
- Country
- BY