Cleared Traditional

WORKSTATIONONE BREAST IMAGING WORKSTATION (K073272) - FDA 510(k) Clearance

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

K073272 · Three Palm Software, LLC · Radiology device
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Dec 2007
Decision
20d
Days
Class 2
Risk

K073272 is an FDA 510(k) clearance for the WORKSTATIONONE BREAST IMAGING WORKSTATION. 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 Three Palm Software, LLC (Los Gatos, US). The FDA issued a Cleared decision on December 11, 2007 after a review of 20 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 Three Palm Software, LLC devices

Submission Details

510(k) Number K073272 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2007
Decision Date December 11, 2007
Days to Decision 20 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
87d faster than avg
Panel avg: 107d · This submission: 20d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 K073272.
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ARTERIAL HEALTH PACKAGE (AHP) SOFTWARE
K083149 · Siemens Medical Solutions USA, Inc. · Jan 2009
INTEGRADWEB PACS SYSTEM
K072986 · Ge Healthcare · Nov 2007
GE ECHOPAC
K072952 · General Electric Co. · Nov 2007
SYNGO TRUED
K071950 · Siemens Medical Solutions USA, Inc. · Jul 2007