Clearance Summary
Adaptive Motion Correction (AMC), CSMC-001A and 4D Airways received FDA 510(k) clearance under submission number K143294, sponsored by Toshibamedical Systems Corporation. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2015-05-15.
- Submission: K143294
- Applicant / Sponsor: Toshibamedical Systems Corporation
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1750
- Decision date: 2015-05-15
Classification & Regulation
This clearance is catalogued under FDA product code JAK and 21 CFR 892.1750, within the Radiology review panel as a Class II device.