Cleared Traditional

K893521 - IMLOGIX 1000 IMAGE DISPLAY SYSTEM

K893521 is an FDA 510(k) clearance for IMLOGIX 1000 IMAGE DISPLAY SYSTEM, manufactured by Imlogix A Div. of Microterm. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K893521 · Imlogix A Div. of Microterm · Radiology device
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Jun 1989
Decision
46d
Days
Class 2
Risk

K893521 is an FDA 510(k) clearance for the IMLOGIX 1000 IMAGE DISPLAY SYSTEM. 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 Imlogix A Div. of Microterm (St. Louis, US). The FDA issued a Cleared decision on June 23, 1989 after a review of 46 days - a notably fast clearance cycle.

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 Imlogix A Div. of Microterm devices

FDA 510(k) Submission Details - K893521

510(k) Number K893521 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 1989
Decision Date June 23, 1989
Days to Decision 46 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 107d · This submission: 46d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LLZ Device Classification - Class 2, Special Controls

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 2092
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K893521.
MEDRAD FLUOROVISION HR 2000, HIGH RESOLUTION IMAGE
K900586 · Medrad, Inc. · Feb 1990
FUJI COMPUTED RADIOGRAPHY SYSTEM FCR AC-1 (FCR)
K896050 · Fujifilm Medical System U.S.A., Inc. · Dec 1989
14 COLOR VIDEO DISPLAY 211-260-010
K893585 · Mennen Medical, Inc. · Jul 1989
DIGISCAN
K884621 · Siemens Medical Solutions USA, Inc. · Apr 1989
SIEMENS PACS/1-B (OPTICAL DISK OPTION)
K884995 · Siemens Gammasonics, Inc. · Feb 1989
DIGITRON 3, LV ANALYSIS PROTCOL
K885318 · Siemens Gammasonics, Inc. · Feb 1989