K153324 is an FDA 510(k) clearance for the Ingenia 1.5T and Ingenia 1.5T S R5.2. This device is classified as a System, Nuclear Magnetic Resonance Imaging (Class II - Special Controls, product code LNH).
Submitted by Philips Medical Systems Nederlands B.V. (Best Noord-Brabant, NL). The FDA issued a Cleared decision on March 22, 2016, 125 days after receiving the submission on November 18, 2015.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K153324 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 18, 2015 |
| Decision Date | March 22, 2016 |
| Days to Decision | 125 days |
| Submission Type | Abbreviated |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LNH — System, Nuclear Magnetic Resonance Imaging |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1000 |