Cleared Traditional

K954172 - X-RAY VISIONS

K954172 is an FDA 510(k) clearance for X-RAY VISIONS, manufactured by Image Visions, LLC. The device is a Class 1 Radiology device with product code LMD cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K954172 · Image Visions, LLC · Radiology device
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Mar 1996
Decision
192d
Days
Class 1
Risk

K954172 is an FDA 510(k) clearance for the X-RAY VISIONS. Classified as System, Digital Image Communications, Radiological (product code LMD), Class I - General Controls.

Submitted by Image Visions, LLC (New York, US). The FDA issued a Cleared decision on March 15, 1996 after a review of 192 days - an extended review 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: 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 Image Visions, LLC devices

FDA 510(k) Submission Details - K954172

510(k) Number K954172 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 1995
Decision Date March 15, 1996
Days to Decision 192 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 107d · This submission: 192d
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
Devices cleared under the same product code (LMD) and FDA review panel - the closest regulatory comparables to K954172.
RTI MEDICAL
K954567 · Radiology Telenetwork Intl. · Apr 1996
PHILIPS SITE VIEW WORKSTATION
K960809 · Philips Medical Systems North America, Inc. · Apr 1996
ACCESS RADIOLOGY TELERADIOLOGY IMAGE ACQUISITION & DISTRIBUTION SYSTEM
K954691 · Access Radiology Corp. · Mar 1996
COMPUMED DICON CLIENT
K955708 · Compumed, Inc. · Mar 1996
IDXVIEW
K954071 · Idx Systems Corp. · Feb 1996
DICOMVIEW
K954479 · Heartlab, Inc. · Feb 1996