K201777 is an FDA 510(k) clearance for the 31HN713D. This device is classified as a Display, Diagnostic Radiology (Class II - Special Controls, product code PGY).
Submitted by Lg Electronics.Inc (Pyeongtaek-Si, KR). The FDA issued a Cleared decision on October 8, 2020, 101 days after receiving the submission on June 29, 2020.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050. The Device Is Intended For Use In Displaying Radiological Images For Review, Analysis, And Diagnosis By Trained Medical Practitioners..
| 510(k) Number | K201777 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 29, 2020 |
| Decision Date | October 08, 2020 |
| Days to Decision | 101 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | PGY — Display, Diagnostic Radiology |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |
| Definition | The Device Is Intended For Use In Displaying Radiological Images For Review, Analysis, And Diagnosis By Trained Medical Practitioners. |