The following data is part of a premarket notification filed by Ge Healthcare Coils (usa Instruments Inc.) with the FDA for 8 Channel Cardiac Phased Array Coil.
| Device ID | K101492 |
| 510k Number | K101492 |
| Device Name: | 8 CHANNEL CARDIAC PHASED ARRAY COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | GE HEALTHCARE COILS (USA INSTRUMENTS INC.) 1515 DANNER DR Aurora, OH 44202 -9273 |
| Contact | Michael S Preto |
| Correspondent | Daniel W Lehtonen INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2010-06-01 |
| Decision Date | 2010-06-23 |
| Summary: | summary |