K150842 is an FDA 510(k) clearance for the JUSHA-M53 Medical Display. 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 April 28, 2015, 29 days after receiving the submission on March 30, 2015.
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 | K150842 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 30, 2015 |
| Decision Date | April 28, 2015 |
| Days to Decision | 29 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. |