510(k) K852346
K852346 is an FDA 510(k) premarket notification submitted by Xi Tech for the device "XISCAN MODEL 1000". The FDA issued a decision of Substantially Equivalent on March 10, 1986. The device falls under product code JAA (System, X-Ray, Fluoroscopic, Image-Intensified), a Class II device regulated under 21 CFR 892.1650.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 10, 1986
- Date Received
- May 31, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Fluoroscopic, Image-Intensified
- Device Class
- Class II
- Regulation Number
- 892.1650
- Review Panel
- RA
- Submission Type