Cleared Traditional

SECURVIEW DX SOFTCOPY WORKSTATION (K041555) - FDA 510(k) Clearance

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

K041555 · Hologic, Inc. · Radiology device
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Aug 2004
Decision
60d
Days
Class 2
Risk

K041555 is an FDA 510(k) clearance for the SECURVIEW DX SOFTCOPY 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 Hologic, Inc. (Bedford, US). The FDA issued a Cleared decision on August 9, 2004 after a review of 60 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 Hologic, Inc. devices

Submission Details

510(k) Number K041555 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2004
Decision Date August 09, 2004
Days to Decision 60 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
47d faster than avg
Panel avg: 107d · This submission: 60d
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 K041555.
MAMMOREPORT SOFTCOPY WORKSTATION
K042868 · Siemens Medical Solutions USA, Inc. · Jan 2005
X-LEONARDO
K042995 · Siemens Medical Solutions USA, Inc. · Nov 2004
LEONARDO SYNGO CARDIOLOGY WORKSTATION
K042203 · Siemens Medical Solutions USA, Inc. · Sep 2004
UNDECIDED
K041484 · Siemens Medical Solutions USA, Inc. · Jul 2004
CONSULTIVA CASE INPUT STATION, MODEL CIS-1
K031132 · Eastman Kodak Company · Nov 2003
KODAK DIRECTVIEW PACS/IMAGE MANAGEMENT SYSTEM, KODAK DIRECTVIEW WORKFLOW MANAGER,KODAK DIRECTVIEW CX/DX, KODAK DIRECTVIB
K030781 · Eastman Kodak Company · May 2003