K191705 is an FDA 510(k) clearance for the OptikView GUP2103CMI. This device is classified as a Display, Diagnostic Radiology (Class II - Special Controls, product code PGY).
Submitted by The Linden Group Corp (Cedar Knolls, US). The FDA issued a Cleared decision on March 16, 2020, 264 days after receiving the submission on June 26, 2019.
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 | K191705 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 26, 2019 |
| Decision Date | March 16, 2020 |
| Days to Decision | 264 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. |