510(k) K974619
K974619 is an FDA 510(k) premarket notification submitted by Afp Imaging Corp. for the device "SCANARAY/CD-DENT ADVANCED COMPUTERIZED X-RAY SYSTEM". The FDA issued a decision of Substantially Equivalent on February 25, 1998. The device falls under product code LMA (Digitizer, Image, Radiological), a Class II device regulated under 21 CFR 892.2030. Afp Imaging Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 25, 1998
- Date Received
- December 11, 1997
- 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