Cleared Traditional

K112480 - VIEW 1 IMAGING (FDA 510(k) Clearance)

K112480 · KARL STORZ Endoscopy-America, Inc. · Radiology device

Dec 2011

Decision

106d

Days

Class 2

Risk

K112480 is an FDA 510(k) clearance for the VIEW 1 IMAGING. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by KARL STORZ Endoscopy-America, Inc. (El Segundo, US). The FDA issued a Cleared decision on December 13, 2011, 106 days after receiving the submission on August 29, 2011.

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

Submission Details

510(k) Number	K112480 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 29, 2011
Decision Date	December 13, 2011
Days to Decision	106 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF