The following data is part of a premarket notification filed by Ge Healthcare Coils (usa Instruments Inc.) with the FDA for 3.0t Gem Rt Open Array.
| Device ID | K143389 |
| 510k Number | K143389 |
| Device Name: | 3.0T GEM RT Open Array |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | GE HEALTHCARE COILS (USA INSTRUMENTS INC.) 1515 DANNER DR Aurora, OH 44202 -9273 |
| Contact | Candice C Mandera |
| Correspondent | Candice C Mandera 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 | 2014-11-26 |
| Decision Date | 2015-03-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682108560 | K143389 | 000 |