Clearance Summary
Digital flat panel detector received FDA 510(k) clearance under submission number K220536, sponsored by Iray Technology Taicang , 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 2022-04-28.
- Submission: K220536
- Applicant / Sponsor: Iray Technology Taicang , Ltd.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2022-04-28
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.