The following data is part of a premarket notification filed by Ge Healthcare Coils (usa Instruments Inc.) with the FDA for 3.0t 16 Channel Head Neck Spine Coil.
| Device ID | K093348 |
| 510k Number | K093348 |
| Device Name: | 3.0T 16 CHANNEL HEAD NECK SPINE COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | GE HEALTHCARE COILS (USA INSTRUMENTS INC.) 3200 N GRANDVIEW BLVD., MAIL CODE : W-827 Waukesha, WI 53188 -9273 |
| Contact | Elizabeth Mathew |
| Correspondent | Daniel 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 | 2009-10-27 |
| Decision Date | 2009-11-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682114264 | K093348 | 000 |