510(k) K191125
K191125 is an FDA 510(k) premarket notification submitted by Galgo Medical S.L for the device "ADAS 3D". The FDA issued a decision of Substantially Equivalent on Jan 15, 2020. 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
- Jan 15, 2020
- Date Received
- Apr 29, 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)