The following data is part of a premarket notification filed by Philips Medical Systems North America, Inc. with the FDA for Tansmit/receive Quadrature Body Coil 3.0t.
| Device ID | K013894 |
| 510k Number | K013894 |
| Device Name: | TANSMIT/RECEIVE QUADRATURE BODY COIL 3.0T |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 22100 BOTHELL EVERETT HWY P.O. BOX 3003 Bothell, WA 98041 -3003 |
| Contact | Lynn Harmer |
| Correspondent | Lynn Harmer PHILIPS MEDICAL SYSTEMS NORTH AMERICA, INC. 22100 BOTHELL EVERETT HWY P.O. BOX 3003 Bothell, WA 98041 -3003 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-23 |
| Decision Date | 2002-01-18 |
| Summary: | summary |