The following data is part of a premarket notification filed by Ge Medical Systems, Llc with the FDA for 1.5 Ge 6-channel Phased Array Flex Coil, 3.0 Ge 6-channel Phased Array Flex Coil.
| Device ID | K110610 |
| 510k Number | K110610 |
| Device Name: | 1.5 GE 6-CHANNEL PHASED ARRAY FLEX COIL, 3.0 GE 6-CHANNEL PHASED ARRAY FLEX COIL |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | GE MEDICAL SYSTEMS, LLC 3200 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | Michelle Scheidt |
| Correspondent | Michelle Scheidt GE MEDICAL SYSTEMS, LLC 3200 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-03 |
| Decision Date | 2011-04-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682119597 | K110610 | 000 |
| 00840682119580 | K110610 | 000 |