Clearance Summary
MXD100/MX 20, OR MX 30, OR MX 40 OR MX 50--(MXD 100 SERIES) received FDA 510(k) clearance under submission number K011111, sponsored by Modular X-Ray Devices. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 2001-05-30.
- Submission: K011111
- Applicant / Sponsor: Modular X-Ray Devices
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1680
- Decision date: 2001-05-30
Classification & Regulation
This clearance is catalogued under FDA product code KPR and 21 CFR 892.1680, within the Radiology review panel as a Class II device.