Cleared Traditional

ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0

K992352 · Inteleradiology, Inc. · Radiology

Sep 1999

Decision

77d

Days

Class 1

Risk

About This 510(k) Submission

K992352 is an FDA 510(k) clearance for the ITR2000: INTERNET TELERADIOLOGY, MODEL RELEASE 1.0, a System, Digital Image Communications, Radiological (Class I — General Controls, product code LMD), submitted by Inteleradiology, Inc. (San Marino, US). The FDA issued a Cleared decision on September 29, 1999, 77 days after receiving the submission on July 14, 1999. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2020.

Submission Details

510(k) Number	K992352 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 14, 1999
Decision Date	September 29, 1999
Days to Decision	77 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.