Clearance Summary
AccuContour received FDA 510(k) clearance under submission number K191928, sponsored by Xiamen Manteia Technology , Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2020-02-28.
- Submission: K191928
- Applicant / Sponsor: Xiamen Manteia Technology , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2020-02-28
Classification & Regulation
This clearance is catalogued under FDA product code QKB and 21 CFR 892.2050, within the Radiology review panel as a Class II device.