Cleared Traditional

K182290 - IBM iConnect Access (FDA 510(k) Clearance)

K182290 · Merge Healthcare Incorporated · Radiology device

Sep 2018

Decision

33d

Days

Class 2

Risk

K182290 is an FDA 510(k) clearance for the IBM iConnect Access. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Merge Healthcare Incorporated (Hartland, US). The FDA issued a Cleared decision on September 25, 2018, 33 days after receiving the submission on August 23, 2018.

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

Submission Details

510(k) Number	K182290 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 23, 2018
Decision Date	September 25, 2018
Days to Decision	33 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF