510(k) K983267
K983267 is an FDA 510(k) premarket notification submitted by Orion Corporation Soredex for the device "DIGORA FOR WINDOWS 2.0". The FDA issued a decision of Substantially Equivalent on December 30, 1998. The device falls under product code MUH (System, X-Ray, Extraoral Source, Digital), a Class II device regulated under 21 CFR 872.1800. Orion Corporation Soredex has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 30, 1998
- Date Received
- September 17, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Extraoral Source, Digital
- Device Class
- Class II
- Regulation Number
- 872.1800
- Review Panel
- RA
- Submission Type