Cleared Abbreviated

K011173 - TELEPAX

K011173 is an FDA 510(k) clearance for TELEPAX, manufactured by Imed Systems & Consulting, LLC. The device is a Class 2 Radiology device with product code LLZ cleared through the Abbreviated 510(k) pathway after a 85-day FDA review.

K011173 · Imed Systems & Consulting, LLC · Radiology device
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Jul 2001
Decision
85d
Days
Class 2
Risk

K011173 is an FDA 510(k) clearance for the TELEPAX. 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 Imed Systems & Consulting, LLC (Westminster, US). The FDA issued a Cleared decision on July 11, 2001 after a review of 85 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Incremental AI imaging tool. Standards-verified equivalence. 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 Imed Systems & Consulting, LLC devices

FDA 510(k) Submission Details - K011173

510(k) Number K011173 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2001
Decision Date July 11, 2001
Days to Decision 85 days
Submission Type Abbreviated
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 107d · This submission: 85d
Pathway characteristics
Standards-based clearance path.

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 1698
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K011173.
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SYNGO MULTIMODALITY WORKSTATION
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ADC QS/IPD WORKSTATION
K010571 · Agfa Corp. · Mar 2001
ADVANTAGE WINDOWS CT/PET FUSION
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