Cleared Traditional

ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONS (K071972) - FDA 510(k) Clearance

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

K071972 · Agfa Healthcare Corp. · Radiology device
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Jul 2007
Decision
13d
Days
Class 2
Risk

K071972 is an FDA 510(k) clearance for the ORTHOPEDIC SOFTWARE FOR IMPAX WORKSTATIONS. 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 Agfa Healthcare Corp. (Greenville, US). The FDA issued a Cleared decision on July 30, 2007 after a review of 13 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 Agfa Healthcare Corp. devices

Submission Details

510(k) Number K071972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 17, 2007
Decision Date July 30, 2007
Days to Decision 13 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
94d faster than avg
Panel avg: 107d · This submission: 13d
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 K071972.
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K072952 · General Electric Co. · Nov 2007
SYNGO TRUED
K071950 · Siemens Medical Solutions USA, Inc. · Jul 2007
SYNGO DYNAMICS, VERSION 6.0
K070322 · Siemens Medical Solutions USA, Inc. · Feb 2007
SYNGO MI APPLICATIONS 2007A
K063826 · Siemens Medical Solutions USA, Inc. · Jan 2007