Cleared Traditional

K122523 - CARESTREAM VUE PACS (FDA 510(k) Clearance)

K122523 · Carestream Health, Inc. · Radiology device

Oct 2012

Decision

64d

Days

Class 2

Risk

K122523 is an FDA 510(k) clearance for the CARESTREAM VUE PACS. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Carestream Health, Inc. (Rochester, US). The FDA issued a Cleared decision on October 23, 2012, 64 days after receiving the submission on August 20, 2012.

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

Submission Details

510(k) Number	K122523 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 20, 2012
Decision Date	October 23, 2012
Days to Decision	64 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement