K170837 is an FDA 510(k) clearance for the Nio Color 3MP (MDNC-3421). This device is classified as a Display, Diagnostic Radiology (Class II - Special Controls, product code PGY).
Submitted by Barco N.V. (Kortrijk, BE). The FDA issued a Cleared decision on April 5, 2017, 15 days after receiving the submission on March 21, 2017.
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 | K170837 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 21, 2017 |
| Decision Date | April 05, 2017 |
| Days to Decision | 15 days |
| Submission Type | Special |
| 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. |