Cleared Traditional

K970174 - FREEPIX/PIXPACS DICOM/HTTP GATEWAY

K970174 is an FDA 510(k) clearance for FREEPIX/PIXPACS DICOM/HTTP GATEWAY, manufactured by Pixelinks, Inc.. The device is a Class 1 Radiology device with product code LMD cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K970174 · Pixelinks, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1997
Decision
111d
Days
Class 1
Risk

K970174 is an FDA 510(k) clearance for the FREEPIX/PIXPACS DICOM/HTTP GATEWAY. Classified as System, Digital Image Communications, Radiological (product code LMD), Class I - General Controls.

Submitted by Pixelinks, Inc. (Morristown, US). The FDA issued a Cleared decision on May 1, 1997 after a review of 111 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2020 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Pixelinks, Inc. devices

FDA 510(k) Submission Details - K970174

510(k) Number K970174 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 10, 1997
Decision Date May 01, 1997
Days to Decision 111 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 107d · This submission: 111d
Pathway characteristics
Predicate-based equivalence.

LMD Device Classification - Class 1, General Controls

Product Code LMD System, Digital Image Communications, Radiological
Device Class Class 1 - 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.
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - LMD System, Digital Image Communications, Radiological

All 45
Devices cleared under the same product code (LMD) and FDA review panel - the closest regulatory comparables to K970174.
GE ADVANTAGE DIGITIZER WORKSTATION
K970628 · Ge Medical Systems, Inc. · May 1997
RIS SCANVIEW SYSTEM (RSVS)
K970641 · Radiology Information Systems, Inc. · May 1997
MITRA IMAGING, INC. FILM EXPRESS SCANNING SOFTWARE
K970652 · Mitra Imaging, Inc. · May 1997
FUJI COMPUTED RADIOGRAPHY FCR/DICOM GATEWAY UNIT CR-DM666
K970293 · Fujifilm Medical System U.S.A., Inc. · Mar 1997
AMICAS WEB/INTRANET IMAGE SERVER
K970064 · Autocyt Group, Inc. · Mar 1997
SMIIC (SECTRA MEDICAL IMAGE INPUT CONTROLLER)
K965161 · Sectra-Imtec AB · Mar 1997