The following data is part of a premarket notification filed by Kineticor, Inc. with the FDA for Motion Correction System.
| Device ID | K193324 |
| 510k Number | K193324 |
| Device Name: | Motion Correction System |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | KinetiCor, Inc. 3465 Waialae Avenue, Suite 300A Honolulu, HI 96816 |
| Contact | Doug Donzelli |
| Correspondent | Scott R. Herr KinetiCor, Inc. 3465 Waialae Avenue, Suite 300A Honolulu, HI 96816 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-02 |
| Decision Date | 2020-02-04 |