Cleared Traditional

K082336 - XR-EXPRESS

K082336 is an FDA 510(k) clearance for XR-EXPRESS, manufactured by New Mexico Software, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K082336 · New Mexico Software, Inc. · Radiology device
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Optimized for regulatory review, auditing and printing
Oct 2008
Decision
62d
Days
Class 2
Risk

K082336 is an FDA 510(k) clearance for the XR-EXPRESS. 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 New Mexico Software, Inc. (Austin, US). The FDA issued a Cleared decision on October 15, 2008 after a review of 62 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 New Mexico Software, Inc. devices

FDA 510(k) Submission Details - K082336

510(k) Number K082336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 2008
Decision Date October 15, 2008
Days to Decision 62 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
45d faster than avg
Panel avg: 107d · This submission: 62d
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 1336
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K082336.
CARESTREAM PACS, MODEL CARESTREAM PACS VII
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IMAGE-ARENA APPLICATIONS
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SYNGO IMAGING XS
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4D VIEWER RADIOLOGY, MODEL USWP-100A
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COLOR LCD MONITOR
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IMAGE-ARENA APPLICATIONS, MODEL IMAGE-ARENA VA PLATFORM 1.0, 4D LV-ANALYSIS 2.5, 4D LV-ANALYSIS MR 1.0
K082510 · Tomtec Imaging Systems GmbH · Oct 2008