The following data is part of a premarket notification filed by Ge Medical Systems, Inc. with the FDA for 3.0t Torso Phased Array Coil.
| Device ID | K030495 |
| 510k Number | K030495 |
| Device Name: | 3.0T TORSO PHASED ARRAY COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | GE MEDICAL SYSTEMS, INC. P.O. BOX 414 Milwaukee, WI 53201 |
| Contact | Larry Kroger |
| Correspondent | Heinz Joerg Steneberg TUV RHEINLAND OF NORTH AMERICA, INC. 1279 QUARRY LANE, SUITE A Pleasanton, CA 94566 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2003-02-19 |
| Decision Date | 2003-03-05 |
| Summary: | summary |