510(k) K853983
K853983 is an FDA 510(k) premarket notification submitted by Canon USA, Inc. for the device "CANON X-RAY 35MM CINE CAMERA CSI-35". The FDA issued a decision of Substantially Equivalent on October 16, 1985. The device falls under product code IZJ (Camera, X-Ray, Fluorographic, Cine Or Spot), a Class II device regulated under 21 CFR 892.1620. Canon USA, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 16, 1985
- Date Received
- September 27, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, X-Ray, Fluorographic, Cine Or Spot
- Device Class
- Class II
- Regulation Number
- 892.1620
- Review Panel
- RA
- Submission Type