Cleared Traditional

ENTEGRA PE PERSONAL DIGITAL ASSISTANT (K014058) - FDA 510(k) Clearance

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

K014058 · General Electric Medical Systems · Radiology device
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Dec 2001
Decision
11d
Days
Class 2
Risk

K014058 is an FDA 510(k) clearance for the ENTEGRA PE PERSONAL DIGITAL ASSISTANT. 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 General Electric Medical Systems (Waukesha, US). The FDA issued a Cleared decision on December 21, 2001 after a review of 11 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 General Electric Medical Systems devices

Submission Details

510(k) Number K014058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 10, 2001
Decision Date December 21, 2001
Days to Decision 11 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
96d faster than avg
Panel avg: 107d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 K014058.
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K010938 · Siemens Medical Solutions USA, Inc. · Jun 2001
ODYSSEY LX, MODEL 211320
K003437 · Philips Medical Systems (Cleveland), Inc. · Feb 2001