Clearance Summary
Customize received FDA 510(k) clearance under submission number K221432, sponsored by 3D-Side S.A.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2022-08-03.
- Submission: K221432
- Applicant / Sponsor: 3D-Side S.A.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.2050
- Decision date: 2022-08-03
Classification & Regulation
This clearance is catalogued under FDA product code QIH and 21 CFR 892.2050, within the Radiology review panel as a Class II device.