K160346 is an FDA 510(k) clearance for the MX30N(MX30TQS). This device is classified as a Display, Diagnostic Radiology (Class II - Special Controls, product code PGY).
Submitted by Wide Corporation (Yongin-Si, KR). The FDA issued a Cleared decision on April 14, 2016, 66 days after receiving the submission on February 8, 2016.
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 | K160346 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 08, 2016 |
| Decision Date | April 14, 2016 |
| Days to Decision | 66 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. |