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 |