K183499 is an FDA 510(k) clearance for the JUSHA-M350G/JUSHA-M350/M350G/M350 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 February 4, 2019, 49 days after receiving the submission on December 17, 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 | K183499 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 17, 2018 |
| Decision Date | February 04, 2019 |
| Days to Decision | 49 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. |