The following data is part of a premarket notification filed by Ge Healthcare with the FDA for 1.5t Air Mp M, 1.5t Air Mp L, 1.5t 16ch Air Aa, 1.5t 30ch Air Aa.
| Device ID | K182590 |
| 510k Number | K182590 |
| Device Name: | 1.5T AIR MP M, 1.5T AIR MP L, 1.5T 16ch AIR AA, 1.5T 30ch AIR AA |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | GE Healthcare 3200 N. Grandview Blvd Waukesha, WI 53188 |
| Contact | Veronica Meridith |
| Correspondent | Veronica Meridith GE Healthcare 1515 Danner Drive Aurora, OH 44202 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-20 |
| Decision Date | 2018-10-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682145626 | K182590 | 000 |
| 00840682145619 | K182590 | 000 |
| 00840682142939 | K182590 | 000 |
| 00840682143011 | K182590 | 000 |