Cleared Traditional

ISITE RADIOLOGY

K013630 · Stentor, Inc. · Radiology

Dec 2001

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K013630 is an FDA 510(k) clearance for the ISITE RADIOLOGY, a System, Image Processing, Radiological (Class II — Special Controls, product code LLZ), submitted by Stentor, Inc. (San Leandro, US). The FDA issued a Cleared decision on December 5, 2001, 30 days after receiving the submission on November 5, 2001. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2050.

Submission Details

510(k) Number	K013630 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 05, 2001
Decision Date	December 05, 2001
Days to Decision	30 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF