Cleared Traditional

CENTRICITY RADIOLOGY RA600/CENTRICITY CARDIOLOGY CA1000/CENTRICITY DIGITAL HARDCOPY WORKSTATION (K042525) - FDA 510(k) Clearance

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

K042525 · Ge Medical Systems Information Technologies · Radiology device
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Oct 2004
Decision
14d
Days
Class 2
Risk

K042525 is an FDA 510(k) clearance for the CENTRICITY RADIOLOGY RA600/CENTRICITY CARDIOLOGY CA1000/CENTRICITY DIGITAL HA.... 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 Ge Medical Systems Information Technologies (Mount Prospect, US). The FDA issued a Cleared decision on October 1, 2004 after a review of 14 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 Ge Medical Systems Information Technologies devices

Submission Details

510(k) Number K042525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 17, 2004
Decision Date October 01, 2004
Days to Decision 14 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 107d · This submission: 14d
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 Consultant

Underwriters Laboratories, Inc.
CHANTEL CARSON

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 799
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K042525.
CENTRICITY PACS SYSTEM
K043415 · Ge Medical Systems Information Technologies · Jan 2005
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
SECURVIEW DX SOFTCOPY WORKSTATION
K041555 · Hologic, Inc. · Aug 2004
UNDECIDED
K041484 · Siemens Medical Solutions USA, Inc. · Jul 2004