Cleared Traditional

K080553 - DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16
(FDA 510(k) Clearance)

K080553 · Vieworks Co., Ltd. · Radiology

Apr 2008

Decision

48d

Days

Class 2

Risk

K080553 is an FDA 510(k) clearance for the DIGITAL RADIOGRAPHY SYSTEM, MODEL QXR-16, a System, X-ray, Stationary (Class II — Special Controls, product code KPR), submitted by Vieworks Co., Ltd. (Flintville, US). The FDA issued a Cleared decision on April 16, 2008, 48 days after receiving the submission on February 28, 2008. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1680.

Submission Details

510(k) Number	K080553 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 28, 2008
Decision Date	April 16, 2008
Days to Decision	48 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF