Qlarity Imaging
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Qlarity Imaging is a medical device manufacturer, with 4 devices listed in FDA GUDID and FDA 510(k) (FDA Class II) as of 13 Nov 2026.
- Devices
- 4
Registry facts
- Registries
- FDA GUDID 3
- FDA 510(k) 1
- Device classes
- FDA Class II 4
What Qlarity Imaging makes
Qlarity Imaging develops radiological Picture Archiving and Communication Systems (PACS) software, including specialized tools for MRI-guided biopsy procedures. The QuantX platform supports image management, analysis, and workflow integration for diagnostic imaging, with a dedicated plugin for breast MRI biopsy guidance.
The company’s products are classified as Class II medical devices under FDA regulations and are listed in the FDA’s 510(k) and Unique Device Identifier (UDI) databases. The portfolio is regulated in the United States.
Catalogue
- Regimes: 510(k) Registry: GUDID
- Regimes: De Novo Registry: GUDID
- Regimes: 510(k) Registry: GUDID
QuantX Breast MRI Biopsy Guidance Plugin Ref K191959
Regimes: 510(k) Registry: 510(k)
Frequently asked questions
How many devices does Qlarity Imaging have in the registry?
The registry currently lists 4 devices for Qlarity Imaging. Devices recorded under merged duplicate company entries are counted once.
Which registries list Qlarity Imaging's devices?
Among its 4 most recently registered devices, Qlarity Imaging has devices listed in FDA 510(k) (1 device) and FDA GUDID (3 devices). A device can be listed in more than one registry, so these counts overlap.
What risk classes do Qlarity Imaging's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Qlarity Imaging's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Qlarity Imaging in the registry?
The most recently registered devices listed for Qlarity Imaging include QuantX Breast MRI SE, QuantX Breast MRI and QuantX Breast MRI Biopsy Guidance Plugin.