The following data is part of a premarket notification filed by Ge Medical Systems, Inc. with the FDA for Signa Profile Quadrature Thoracic/lumbar Spine Phased Array Coil.
| Device ID | K982772 |
| 510k Number | K982772 |
| Device Name: | SIGNA PROFILE QUADRATURE THORACIC/LUMBAR SPINE PHASED ARRAY COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | GE MEDICAL SYSTEMS, INC. P.O. BOX 414 Milwaukee, WI 53201 |
| Contact | Larry A Kroger |
| Correspondent | Larry A Kroger GE MEDICAL SYSTEMS, INC. P.O. BOX 414 Milwaukee, WI 53201 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-08-07 |
| Decision Date | 1998-10-15 |
| Summary: | summary |