Cleared Traditional

K973793 - OLICON IMAGING SYSTEMS, INC. GATEWAY AND/OR SOFTWARE

K973793 is an FDA 510(k) clearance for OLICON IMAGING SYSTEMS, manufactured by Olicon Imaging Systems, Inc.. The device is a Class 1 Radiology device with product code LMD cleared through the Traditional 510(k) pathway after a 72-day FDA review.

K973793 · Olicon Imaging Systems, Inc. · Radiology device
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Dec 1997
Decision
72d
Days
Class 1
Risk

K973793 is an FDA 510(k) clearance for the OLICON IMAGING SYSTEMS, INC. GATEWAY AND/OR SOFTWARE. Classified as System, Digital Image Communications, Radiological (product code LMD), Class I - General Controls.

Submitted by Olicon Imaging Systems, Inc. (Plano, US). The FDA issued a Cleared decision on December 17, 1997 after a review of 72 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Olicon Imaging Systems, Inc. devices

FDA 510(k) Submission Details - K973793

510(k) Number K973793 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 1997
Decision Date December 17, 1997
Days to Decision 72 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
35d faster than avg
Panel avg: 107d · This submission: 72d
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 79
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