K182291 is an FDA 510(k) clearance for the 6MP Color LCD Monitor (C61W+). 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 November 20, 2018, 89 days after receiving the submission on August 23, 2018.
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 | K182291 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 23, 2018 |
| Decision Date | November 20, 2018 |
| Days to Decision | 89 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. |