Clearance Summary
TrueView Core 100Pro-US Core Specimen Radiography System (TrueView Core 100Pro-US) received FDA 510(k) clearance under submission number K230140, sponsored by Compai Healthcare (Suzhou) Co.,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 2023-04-24.
- Submission: K230140
- Applicant / Sponsor: Compai Healthcare (Suzhou) Co.,Ltd
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2023-04-24
Classification & Regulation
This clearance is catalogued under FDA product code MWP and 21 CFR 892.1680, within the Radiology review panel as a Class II device.