Cleared Traditional

K031372 - PERSONAL DIGITAL WORKSTATION (PDW)

Also marketed or referenced as:
FILM DIGITIZING CAMERA AND DIGITAL WORKSTATION

K031372 is an FDA 510(k) clearance for PERSONAL DIGITAL WORKSTATION (PDW), manufactured by Maxxvision, LLC. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 63-day FDA review.

K031372 · Maxxvision, LLC · Radiology device
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Jul 2003
Decision
63d
Days
Class 2
Risk

K031372 is an FDA 510(k) clearance for the PERSONAL DIGITAL WORKSTATION (PDW). 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 Maxxvision, LLC (Gainesville, US). The FDA issued a Cleared decision on July 2, 2003 after a review of 63 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 Maxxvision, LLC devices

FDA 510(k) Submission Details - K031372

510(k) Number K031372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2003
Decision Date July 02, 2003
Days to Decision 63 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 107d · This submission: 63d
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 1601
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