Cleared Traditional

K952313 - VARIS IMAGES

K952313 is the FDA 510(k) clearance for VARIS IMAGES by Varian Assoc., Inc.. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K952313 · Varian Assoc., Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1995
Decision
91d
Days
Class 2
Risk

K952313 is an FDA 510(k) clearance for the VARIS IMAGES, INCLUDING XIMATRON DIGITAL IMAGING OPTION. Classified as System, Image Processing, Radiological within the LLZ classification (a category encompassing advanced image processing and PACS-adjacent software), Class II - Special Controls.

Submitted by Varian Assoc., Inc. (Palo Alto, US). The FDA issued a Cleared decision on August 16, 1995 after a review of 91 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.2050 - 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: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Varian Assoc., Inc. devices

Submission Details

510(k) Number K952313 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 1995
Decision Date August 16, 1995
Days to Decision 91 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
16d faster than avg
Panel avg: 107d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LLZ System, Image Processing, Radiological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 1132
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K952313.
HP ECHO IMAGE MANAGEMENT SYSTEM
K954668 · Hewlett-Packard Co. · Nov 1995
PHILIPS EASYVISION
K953095 · Philips Medical Systems, Inc. · Nov 1995
FUJI COMPUTED RADIOGRAPHY SYSTEM FCR9501ES.FCR
K952862 · Fujifilm Medical System U.S.A., Inc. · Sep 1995
ALALYSIS PACKAGE FOR DENTAL APPLICATIONS FOR XPEED, XPRESS, XVISION
K953164 · Toshiba America Medical Systems, In.C · Aug 1995
IVR MASTER
K945389 · Shimadzu Corp. · Feb 1995
DFS-700
K945388 · Shimadzu Corp. · Jan 1995