Cleared Traditional

COURIER II

K953514 · Gammex, Inc. · Radiology

Oct 1995

Decision

73d

Days

Class 1

Risk

About This 510(k) Submission

K953514 is an FDA 510(k) clearance for the COURIER II, a System, Digital Image Communications, Radiological (Class I — General Controls, product code LMD), submitted by Gammex, Inc. (Middleton, US). The FDA issued a Cleared decision on October 7, 1995, 73 days after receiving the submission on July 26, 1995. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2020.

Submission Details

510(k) Number	K953514 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 26, 1995
Decision Date	October 07, 1995
Days to Decision	73 days
Submission Type	Traditional
Review Panel	Radiology (RA)
Summary	Summary PDF

Device Classification

Product Code	LMD — System, Digital Image Communications, Radiological
Device Class	Class I — General Controls
CFR Regulation	21 CFR 892.2020
Definition	A Medical Image Communications Device Provides Electronic Transfer Of Medical Image Data Between Medical Devices. It May Include A Physical Communications Medium, Modems, Interfaces, And A Communications Protocol. It May Provide Simple Image Review Software Functionality For Medical Image Processing And Manipulation, Such As Grayscale Window And Level, Zoom And Pan, User Delineated Geometric Measurements, Compression, Or User Added Image Annotations. The Device Does Not Perform Advanced Image Processing Or Complex Quantitative Functions.