Cleared Traditional

K021072 - FILMSAVER, NT VERSION 5.03

K021072 is an FDA 510(k) clearance for FILMSAVER, manufactured by American Medical Resources, Ltd. (Amr). The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 65-day FDA review.

K021072 · American Medical Resources, Ltd. (Amr) · Radiology device
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Jun 2002
Decision
65d
Days
Class 2
Risk

K021072 is an FDA 510(k) clearance for the FILMSAVER, NT VERSION 5.03. 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 American Medical Resources, Ltd. (Amr) (Wilmington, US). The FDA issued a Cleared decision on June 6, 2002 after a review of 65 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 American Medical Resources, Ltd. (Amr) devices

FDA 510(k) Submission Details - K021072

510(k) Number K021072 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 02, 2002
Decision Date June 06, 2002
Days to Decision 65 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
42d faster than avg
Panel avg: 107d · This submission: 65d
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.

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