Cleared Traditional

K001012 - DIGITAL INTEGRATION SYSTEM, DIS2000

K001012 is an FDA 510(k) clearance for DIGITAL INTEGRATION SYSTEM, manufactured by Wellington Medical Systems, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K001012 · Wellington Medical Systems, Inc. · Radiology device
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Jun 2000
Decision
76d
Days
Class 2
Risk

K001012 is an FDA 510(k) clearance for the DIGITAL INTEGRATION SYSTEM, DIS2000. 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 Wellington Medical Systems, Inc. (Dartmouth, US). The FDA issued a Cleared decision on June 13, 2000 after a review of 76 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 Wellington Medical Systems, Inc. devices

FDA 510(k) Submission Details - K001012

510(k) Number K001012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 29, 2000
Decision Date June 13, 2000
Days to Decision 76 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
31d faster than avg
Panel avg: 107d · This submission: 76d
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 1773
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