K191125 is an FDA 510(k) clearance for the ADAS 3D. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by Galgo Medical S.L (Barcelona, ES). The FDA issued a Cleared decision on January 15, 2020, 261 days after receiving the submission on April 29, 2019.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K191125 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 29, 2019 |
| Decision Date | January 15, 2020 |
| Days to Decision | 261 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LLZ - System, Image Processing, Radiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |