Clearance Summary
RT-125 ROUGH TERRAIN MOBILE X-RAY UNIT received FDA 510(k) clearance under submission number K894643, sponsored by Lorad Medical Systems, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Radiology review panel. The statutory decision date of record is 1989-12-14.
- Submission: K894643
- Applicant / Sponsor: Lorad Medical Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Radiology
- Device class: Class II
- Regulation citation: 21 CFR 892.1720
- Decision date: 1989-12-14
Classification & Regulation
This clearance is catalogued under FDA product code IZL and 21 CFR 892.1720, within the Radiology review panel as a Class II device.