Cleared Traditional

K110077 - NEUCOLONCARE (FDA 510(k) Clearance)

K110077 · Neusoft Medical Systems Co., Ltd. · Radiology device

Jan 2011

Decision

17d

Days

Class 2

Risk

K110077 is an FDA 510(k) clearance for the NEUCOLONCARE. This device is classified as a System, Image Processing, Radiological (Class II - Special Controls, product code LLZ).

Submitted by Neusoft Medical Systems Co., Ltd. (Shenyang, Liaoning, CN). The FDA issued a Cleared decision on January 28, 2011, 17 days after receiving the submission on January 11, 2011.

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

Submission Details

510(k) Number	K110077 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 11, 2011
Decision Date	January 28, 2011
Days to Decision	17 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF