510(k) K960839
K960839 is an FDA 510(k) premarket notification submitted by Cannon U.S.A., Inc. for the device "FILM SCANNER 300". The FDA issued a decision of Substantially Equivalent on December 18, 1996. The device falls under product code LMA (Digitizer, Image, Radiological), a Class II device regulated under 21 CFR 892.2030. Cannon U.S.A., Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 18, 1996
- Date Received
- February 26, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Digitizer, Image, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2030
- Review Panel
- RA
- Submission Type