The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Gem Option For 1.5 Mri Systems.
| Device ID | K103335 |
| 510k Number | K103335 |
| Device Name: | GEM OPTION FOR 1.5 MRI SYSTEMS |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | GE HEALTHCARE 1515 DANNER DR. Aurora, OH 44202 |
| Contact | Michael S Preto |
| Correspondent | Michael S Preto GE HEALTHCARE 1515 DANNER DR. 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 | 2010-11-15 |
| Decision Date | 2011-03-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682118521 | K103335 | 000 |
| 00840682118491 | K103335 | 000 |
| 00840682117838 | K103335 | 000 |
| 00840682115780 | K103335 | 000 |