The following data is part of a premarket notification filed by Spintech, Inc. with the FDA for Spin-swi.
| Device ID | K173224 |
| 510k Number | K173224 |
| Device Name: | SPIN-SWI |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | SpinTech, Inc. 30200 Telegraph Road Suite 140 Bingham Farms, MI 48025 |
| Contact | Kay Fuller |
| Correspondent | Kay Fuller SpinTech, Inc. 30200 Telegraph Road Suite 140 Bingham Farms, MI 48025 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-10-03 |
| Decision Date | 2018-02-23 |
| Summary: | summary |