K212837 is an FDA 510(k) clearance for the ProxiDiagnost N90. This device is classified as a System, X-ray, Fluoroscopic, Image-intensified (Class II - Special Controls, product code JAA).
Submitted by Philips Medical Systems Dmc GmbH (Hamburg, DE). The FDA issued a Cleared decision on September 21, 2021, 14 days after receiving the submission on September 7, 2021.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1650.
| 510(k) Number | K212837 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 07, 2021 |
| Decision Date | September 21, 2021 |
| Days to Decision | 14 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | JAA — System, X-ray, Fluoroscopic, Image-intensified |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1650 |