Clearance Summary
HAD1717MC received FDA 510(k) clearance under submission number K200018, sponsored by H&Abyz. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2020-01-31.
- Submission: K200018
- Applicant / Sponsor: H&Abyz
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2020-01-31
Classification & Regulation
This clearance is catalogued under FDA product code MQB and 21 CFR 892.1680, within the Radiology review panel as a Class II device.