510(k) K190162
K190162 is an FDA 510(k) premarket notification submitted by Ortho2, LLC for the device "SmartCeph". The FDA issued a decision of Substantially Equivalent on Oct 17, 2019. 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
- Oct 17, 2019
- Date Received
- Jan 31, 2019
- 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)