The following data is part of a premarket notification filed by Philips Medical Systems(cleveland), Inc. with the FDA for Epi-ii System Option W/high Performance Gradients.
| Device ID | K954646 |
| 510k Number | K954646 |
| Device Name: | EPI-II SYSTEM OPTION W/HIGH PERFORMANCE GRADIENTS |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 5500 AVION PARK DR. Highland Heights, OH 44143 |
| Contact | Elaine K Keeler |
| Correspondent | Elaine K Keeler PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC. 5500 AVION PARK DR. Highland Heights, 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 | 1995-10-10 |
| Decision Date | 1996-01-18 |
| Summary: | summary |