K202374 is an FDA 510(k) clearance for the 4MP/8MP Color LCD Monitors C44W+/C82W+, C83W+, C85W+. This device is classified as a Display, Diagnostic Radiology (Class II - Special Controls, product code PGY).
Submitted by Shenzhen Beacon Display Technology Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 19, 2020, 61 days after receiving the submission on August 19, 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 | K202374 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 19, 2020 |
| Decision Date | October 19, 2020 |
| Days to Decision | 61 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. |