Cleared Traditional

XEBRA DICOM IMAGE BROWSER (K071894) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K071894 · Hx Technologies, Inc. · Radiology device
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Aug 2007
Decision
38d
Days
Class 2
Risk

K071894 is an FDA 510(k) clearance for the XEBRA DICOM IMAGE BROWSER. 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 Hx Technologies, Inc. (Philadelphia, US). The FDA issued a Cleared decision on August 16, 2007 after a review of 38 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 Hx Technologies, Inc. devices

Submission Details

510(k) Number K071894 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2007
Decision Date August 16, 2007
Days to Decision 38 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 107d · This submission: 38d
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 757
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K071894.
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K071950 · Siemens Medical Solutions USA, Inc. · Jul 2007
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K070322 · Siemens Medical Solutions USA, Inc. · Feb 2007
SYNGO MI APPLICATIONS 2007A
K063826 · Siemens Medical Solutions USA, Inc. · Jan 2007