The following data is part of a premarket notification filed by Philips Medical Systems(cleveland), Inc. with the FDA for Infinion 1.5t Mr Imaging System, Model Mri 100.
| Device ID | K003853 |
| 510k Number | K003853 |
| Device Name: | INFINION 1.5T MR IMAGING SYSTEM, MODEL MRI 100 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 595 MINER RD. Cleveland, OH 44143 |
| Contact | Duane Praschan |
| Correspondent | Duane Praschan PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 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 | 2000-12-12 |
| Decision Date | 2001-02-13 |