510(k) K151371
K151371 is an FDA 510(k) premarket notification submitted by U.S. Army Dental Command (Dencom) for the device "Corporate Dental Imaging (CDI) Application". The FDA issued a decision of Substantially Equivalent on Aug 19, 2015. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 19, 2015
- Date Received
- May 21, 2015
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- System, Image Processing, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type
- 510(k)