Cleared Traditional

EFILM WORKSTATION WITH MODULES (K020995) - FDA 510(k) Clearance

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

K020995 · Efilm Medical, Inc. · Radiology device
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Apr 2002
Decision
15d
Days
Class 2
Risk

K020995 is an FDA 510(k) clearance for the EFILM WORKSTATION WITH MODULES. 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 Efilm Medical, Inc. (Toronto, Ontario, CA). The FDA issued a Cleared decision on April 12, 2002 after a review of 15 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 Efilm Medical, Inc. devices

Submission Details

510(k) Number K020995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 2002
Decision Date April 12, 2002
Days to Decision 15 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
92d faster than avg
Panel avg: 107d · This submission: 15d
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 758
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K020995.
SYNGO COLONOGRAPHY SOFTWARE PACKAGE
K030982 · Siemens Medical Solutions USA, Inc. · Apr 2003
CENTRICITY PACS PLUS
K023557 · GE Medical Systems · Nov 2002
E.CAM COMPUTER / E.SOFT WORKSTATION
K023190 · Siemens Medical Solutions USA, Inc. · Oct 2002
ADVANTAGE WORKSTATION 4.1
K020483 · GE Medical Systems · Feb 2002
KODAK RADIATION ONCOLOGY SOFTWARE/ FOR ACR SYSTEMS
K012155 · Eastman Kodak Company · Aug 2001
SYNGO MULTIMODALITY WORKSTATION
K010938 · Siemens Medical Solutions USA, Inc. · Jun 2001