The following data is part of a premarket notification filed by Igc-medical Advances, Inc. with the FDA for Model 545ph Series: Phased Array Musculo-skeletal Flex Coil.
| Device ID | K003366 |
| 510k Number | K003366 |
| Device Name: | MODEL 545PH SERIES: PHASED ARRAY MUSCULO-SKELETAL FLEX COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | IGC-MEDICAL ADVANCES, INC. 10437 INNOVATION DR. Milwaukee, WI 53226 |
| Contact | Michael J Leigh |
| Correspondent | Michael J Leigh IGC-MEDICAL ADVANCES, INC. 10437 INNOVATION DR. Milwaukee, WI 53226 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-10-30 |
| Decision Date | 2000-12-22 |