The following data is part of a premarket notification filed by Philips Medical Systems Nederland B.v. with the FDA for Mdixon-quant.
| Device ID | K133526 |
| 510k Number | K133526 |
| Device Name: | MDIXON-QUANT |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 595 MINER RD. Clevland, OH 44143 |
| Contact | Susan Quick |
| Correspondent | Susan Quick PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 595 MINER RD. Clevland, OH 44143 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-15 |
| Decision Date | 2014-02-12 |
| Summary: | summary |