K161061 is an FDA 510(k) clearance for the IMPAX Volume Viewing 4.0. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).
Submitted by Agfa Healthcare N.V. (Mortsel, BE). The FDA issued a Cleared decision on June 22, 2016, 68 days after receiving the submission on April 15, 2016.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.
| 510(k) Number | K161061 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 15, 2016 |
| Decision Date | June 22, 2016 |
| Days to Decision | 68 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LLZ — System, Image Processing, Radiological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.2050 |