The following data is part of a premarket notification filed by Ge Healthcare Coils (usa Instruments Inc.) with the FDA for Discovery 3t 16 Ch Body Array Coil (anterior); Discovery 3t 16 Ch Body Array Coil (posterior); Discovery 3t 32 Ch Body A.
| Device ID | K103365 |
| 510k Number | K103365 |
| Device Name: | DISCOVERY 3T 16 CH BODY ARRAY COIL (ANTERIOR); DISCOVERY 3T 16 CH BODY ARRAY COIL (POSTERIOR); DISCOVERY 3T 32 CH BODY A |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | GE HEALTHCARE COILS (USA INSTRUMENTS INC.) 1515 DANNER DR Aurora, OH 44202 -9273 |
| Contact | Michael S Preto |
| Correspondent | Michael S Preto GE HEALTHCARE COILS (USA INSTRUMENTS INC.) 1515 DANNER DR Aurora, OH 44202 -9273 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-11-17 |
| Decision Date | 2011-01-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682120067 | K103365 | 000 |
| 00840682120050 | K103365 | 000 |