510(k) K190074
K190074 is an FDA 510(k) premarket notification submitted by Certis Health for the device "Presero 3D Scanning System". The FDA issued a decision of Substantially Equivalent on Feb 14, 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
- Feb 14, 2019
- Date Received
- Jan 16, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Image Processing, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type
- 510(k)