K160328 is an FDA 510(k) clearance for the DIVA ZSP2105CMI with QUBYX PerfectLum bundle. 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 February 25, 2016, 20 days after receiving the submission on February 5, 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 | K160328 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 05, 2016 |
| Decision Date | February 25, 2016 |
| Days to Decision | 20 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. |