Cleared Traditional

STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEM

K984000 · Surgical Navigation Technologies, Inc. · Radiology

Jan 1999

Decision

63d

Days

Class 1

Risk

About This 510(k) Submission

K984000 is an FDA 510(k) clearance for the STEALTHSERVER IMAGE STORAGE AND COMMUNICATION SYSTEM, a System, Digital Image Communications, Radiological (Class I — General Controls, product code LMD), submitted by Surgical Navigation Technologies, Inc. (Broomfield, US). The FDA issued a Cleared decision on January 12, 1999, 63 days after receiving the submission on November 10, 1998. This device falls under the Radiology review panel. Regulated under 21 CFR 892.2020.

Submission Details

510(k) Number	K984000 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 10, 1998
Decision Date	January 12, 1999
Days to Decision	63 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.