K173507 is an FDA 510(k) clearance for the Prodiva 1.5T CX and Prodiva 1.5T CS R5.4. This device is classified as a System, Nuclear Magnetic Resonance Imaging (Class II - Special Controls, product code LNH).
Submitted by Philips Healthcare (Suzhou) Co., Ltd. (Suzhou, CN). The FDA issued a Cleared decision on June 15, 2018, 214 days after receiving the submission on November 13, 2017.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K173507 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 13, 2017 |
| Decision Date | June 15, 2018 |
| Days to Decision | 214 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 |