Clearance Summary
Qmenta Care Platform Family received FDA 510(k) clearance under submission number K202718, sponsored by Mint Labs, Inc., D/B/A. Qmenta. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2021-06-16.
- Submission: K202718
- Applicant / Sponsor: Mint Labs, Inc., D/B/A. Qmenta
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2021-06-16
Classification & Regulation
This clearance is catalogued under FDA product code LLZ and 21 CFR 892.2050, within the Radiology review panel as a Class II device.