Cleared Traditional

PID-1 PRECISION INTELLIGENT DOSIMETER

K954564 · Gammex, Inc. · Radiology

Apr 1996

Decision

203d

Days

Class 2

Risk

About This 510(k) Submission

K954564 is an FDA 510(k) clearance for the PID-1 PRECISION INTELLIGENT DOSIMETER, a Accelerator, Linear, Medical (Class II — Special Controls, product code IYE), submitted by Gammex, Inc. (Middleton, US). The FDA issued a Cleared decision on April 22, 1996, 203 days after receiving the submission on October 2, 1995. This device falls under the Radiology review panel. Regulated under 21 CFR 892.5050.

Submission Details

510(k) Number	K954564 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 02, 1995
Decision Date	April 22, 1996
Days to Decision	203 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF