510(k) K920347
K920347 is an FDA 510(k) premarket notification submitted by Control-X, Inc. for the device "TOP-X 650HF RADIOGRAPHIC X-RAY". The FDA issued a decision of Substantially Equivalent on May 17, 1993. The device falls under product code KPR (System, X-Ray, Stationary), a Class II device regulated under 21 CFR 892.1680. Control-X, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 17, 1993
- Date Received
- January 24, 1992
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Stationary
- Device Class
- Class II
- Regulation Number
- 892.1680
- Review Panel
- RA
- Submission Type