The following data is part of a premarket notification filed by Philips Medical Systems, Inc. with the FDA for Synergy Spine Array Coil.
| Device ID | K033662 |
| 510k Number | K033662 |
| Device Name: | SYNERGY SPINE ARRAY COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | PHILIPS MEDICAL SYSTEMS, INC. 595 MINER RD. Highland Hgts., OH 44143 |
| Contact | Duane C Praschan |
| Correspondent | Duane C Praschan PHILIPS MEDICAL SYSTEMS, INC. 595 MINER RD. Highland Hgts., OH 44143 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-21 |
| Decision Date | 2004-02-02 |
| Summary: | summary |