510(k) K920393
K920393 is an FDA 510(k) premarket notification submitted by Shimadzu Medical Systems for the device "MU125M MOBILE X-RAY SYSTEM". The FDA issued a decision of Substantially Equivalent on April 6, 1992. The device falls under product code IZG (System, X-Ray, Photofluorographic), a Class II device regulated under 21 CFR 892.1730. Shimadzu Medical Systems has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 6, 1992
- Date Received
- January 30, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Photofluorographic
- Device Class
- Class II
- Regulation Number
- 892.1730
- Review Panel
- RA
- Submission Type