QuantX Breast MRI SE
QuantX Breast MRI SE (3) is a Class II device made by Qlarity Imaging, cleared under FDA 510(k) K170195 on 17 May 2017 and listed in FDA GUDID since 19 Feb 2020 (UDI-DI B80731), active (FDA 510(k)), not in commercial distribution (GUDID) as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | NumberB80731 | Date19 Feb 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK170195 | Date17 May 2017 | StatusActive |
Official records
- FDA 510(k) database K170195
Across registries
- FDA 510(k) K170195 decided 17 May 2017 Active
- FDA GUDID UDI-DI B80731 listed 19 Feb 2020 Listed
Timeline
- Cleared FDA 510(k) K170195
- Listed FDA GUDID B80731
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- QuantX
- Generic name
- Radiological PACS-dedicated management software
- Model / Ref / Catalog
- Breast MRI SE, 3
- Primary DI / UDI-DI
- B80731
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- Radiological PACS-dedicated management software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- Not in Commercial Distribution
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