Clearance Summary
Focus HD 43 Detector received FDA 510(k) clearance under submission number K213529, sponsored by Iray Technology Taicang , Ltd.. The device was reviewed via the Special premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2022-03-29.
- Submission: K213529
- Applicant / Sponsor: Iray Technology Taicang , Ltd.
- Clearance pathway: Special
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2022-03-29
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.