K212231 is an FDA 510(k) clearance for the C1210G LCD Monitor, JUSHA-C1210G LCD Monitor, C1210 LCD Monitor, JUSHA-C1210 LCD Monitor. This device is classified as a Display, Diagnostic Radiology (Class II - Special Controls, product code PGY).
Submitted by Nanjing Jusha Display Technology Co., Ltd. (Nanjing, CN). The FDA issued a Cleared decision on March 25, 2022, 252 days after receiving the submission on July 16, 2021.
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 | K212231 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 16, 2021 |
| Decision Date | March 25, 2022 |
| Days to Decision | 252 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. |