510(k) K894643
K894643 is an FDA 510(k) premarket notification submitted by Lorad Medical Systems, Inc. for the device "RT-125 ROUGH TERRAIN MOBILE X-RAY UNIT". The FDA issued a decision of Substantially Equivalent on December 14, 1989. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. Lorad Medical Systems, Inc. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 14, 1989
- Date Received
- July 24, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Mobile
- Device Class
- Class II
- Regulation Number
- 892.1720
- Review Panel
- RA
- Submission Type