Cleared Traditional

COLLIMATOR, MODEL M-38

K062788 · Umi International · Radiology

Dec 2006

Decision

101d

Days

Class 2

Risk

About This 510(k) Submission

K062788 is an FDA 510(k) clearance for the COLLIMATOR, MODEL M-38, a Device, Beam Limiting, X-ray, Diagnostic (Class II — Special Controls, product code KPW), submitted by Umi International (Norwood, US). The FDA issued a Cleared decision on December 28, 2006, 101 days after receiving the submission on September 18, 2006. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1610.

Submission Details

510(k) Number	K062788 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 18, 2006
Decision Date	December 28, 2006
Days to Decision	101 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Statement