Clearance Summary
FLEXITRON received FDA 510(k) clearance under submission number K070574, sponsored by Isodose Control B.V.. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2007-04-13.
- Submission: K070574
- Applicant / Sponsor: Isodose Control B.V.
- Clearance pathway: Abbreviated
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.5700
- Decision date: 2007-04-13
Classification & Regulation
This clearance is catalogued under FDA product code JAQ and 21 CFR 892.5700, within the Radiology review panel as a Class II device.