Gamma Medica-Ideas Incorporated
United StatesFDA applicant, unverified
- Devices
- 2
What Gamma Medica-Ideas Incorporated makes
Gamma Medica-Ideas Incorporated develops software and imaging systems for molecular breast imaging, including diagnostic tools designed to enhance early detection of breast cancer through advanced imaging techniques.
The company’s portfolio includes Class I and Class II devices, with products authorised via the FDA’s 510(k) pathway. These systems are listed under US regulatory frameworks and the company is headquartered in the United States.
Catalogue
Molecular Breast Imaging Software Ref K111731
Regimes: 510(k) Registry: 510(k)Lumagem Molecular Breast Imaging System Ref K111791
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Gamma Medica-Ideas Incorporated have in the registry?
The registry currently lists 2 devices for Gamma Medica-Ideas Incorporated. Devices recorded under merged duplicate company entries are counted once.
Which registries list Gamma Medica-Ideas Incorporated's devices?
Among its 2 most recently registered devices, Gamma Medica-Ideas Incorporated has devices listed in FDA 510(k) (2 devices).
What risk classes do Gamma Medica-Ideas Incorporated's devices fall under?
Among its 2 most recently registered devices, the classes recorded for Gamma Medica-Ideas Incorporated's devices are Class I and Class II. Each device page shows its own class and authorisation.
What are the newest devices from Gamma Medica-Ideas Incorporated in the registry?
The most recently registered devices listed for Gamma Medica-Ideas Incorporated include MOLECULAR BREAST IMAGING SOFTWARE and LUMAGEM MOLECULAR BREAST IMAGING SYSTEM.