Cleared Traditional

K013098 - KIMAX REMOTE VIEWING STATION (FDA 510(k) Clearance)

K013098 · Medical Metrics, Inc. · Radiology device

Dec 2001

Decision

81d

Days

Class 2

Risk

K013098 is an FDA 510(k) clearance for the KIMAX REMOTE VIEWING STATION. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Medical Metrics, Inc. (Chevy Chase, US). The FDA issued a Cleared decision on December 7, 2001, 81 days after receiving the submission on September 17, 2001.

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

Submission Details

510(k) Number	K013098 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 17, 2001
Decision Date	December 07, 2001
Days to Decision	81 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement