Motion Correction System

FDA 510(k) K193324 · Kineticor, Inc.

Substantially Equivalent

510(k) numberK193324

Submission

Device name
Motion Correction System
Applicant
Kineticor, Inc.
Honolulu, HI, US
Received
December 2, 2019
Decision date
February 4, 2020
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LNH – System, Nuclear Magnetic Resonance Imaging
Device class
Class II (moderate risk)
Regulation
21 CFR 892.1000
Specialty
Radiology

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Questions and answers

When was Motion Correction System cleared by the FDA?

Motion Correction System (K193324) received a 510(k) decision of Substantially Equivalent on February 4, 2020, 64 days after the submission was received.

What is the product code of K193324?

The FDA product code is LNH – System, Nuclear Magnetic Resonance Imaging, a Class II (moderate risk) device regulated under 21 CFR 892.1000.