Cleared Traditional

K190993 - Kinepict Medical Imaging Tool version v2.2 (FDA 510(k) Clearance)

K190993 · Kinepict Health, Ltd. · Radiology device

Mar 2020

Decision

324d

Days

Class 2

Risk

K190993 is an FDA 510(k) clearance for the Kinepict Medical Imaging Tool version v2.2. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Kinepict Health, Ltd. (Budakeszi, HU). The FDA issued a Cleared decision on March 5, 2020, 324 days after receiving the submission on April 16, 2019.

This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K190993 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 16, 2019
Decision Date	March 05, 2020
Days to Decision	324 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF