The following data is part of a premarket notification filed by Philips Medical Systems Nederland B.v. with the FDA for Mr Elastography.
| Device ID | K140666 |
| 510k Number | K140666 |
| Device Name: | MR ELASTOGRAPHY |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 595 MINER RD Cleveland, OH 44143 |
| Contact | Susan Quick |
| Correspondent | Susan Quick PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. 595 MINER RD Cleveland, 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 | 2014-03-18 |
| Decision Date | 2014-06-13 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838068476 | K140666 | 000 |