510(k) K790393
K790393 is an FDA 510(k) premarket notification submitted by General X-Ray, Inc. for the device "PORTABLE X-RAY UNIT, MATRIX S GX-101". The FDA issued a decision of Substantially Equivalent on March 26, 1979. The device falls under product code IZL (System, X-Ray, Mobile), a Class II device regulated under 21 CFR 892.1720. General X-Ray, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 26, 1979
- Date Received
- February 26, 1979
- 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