Cleared Traditional

K162474 - Artemis
(FDA 510(k) Clearance)

K162474 · Eigen · Radiology
Oct 2016
Decision
45d
Days
Class 2
Risk

K162474 is an FDA 510(k) clearance for the Artemis. This device is classified as a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ).

Submitted by Eigen (Grass Valley, US). The FDA issued a Cleared decision on October 21, 2016, 45 days after receiving the submission on September 6, 2016.

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

Submission Details

510(k) Number K162474 FDA.gov
FDA Decision Cleared SESE
Date Received September 06, 2016
Decision Date October 21, 2016
Days to Decision 45 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code LLZ — System, Image Processing, Radiological
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.2050