The following data is part of a premarket notification filed by Ivy Biomedical Systems, Inc with the FDA for Mr Wireless Gating System, Model Wgs-100.
| Device ID | K171778 |
| 510k Number | K171778 |
| Device Name: | MR Wireless Gating System, Model WGS-100 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | Ivy Biomedical Systems, Inc 11 Business Park Drive Branford, CT 06405 |
| Contact | Nicole Bush |
| Correspondent | Nicole Bush Ivy Biomedical Systems, Inc 11 Business Park Drive Branford, CT 06405 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-15 |
| Decision Date | 2018-03-14 |