Cleared Special

K121387 - CENTRICITY PACS-IW

K121387 is an FDA 510(k) clearance for CENTRICITY PACS-IW, manufactured by Ge Healthcare Integrated IT Solutions. The device is a Class 2 Radiology device with product code LLZ cleared through the Special 510(k) pathway after a 28-day FDA review.

K121387 · Ge Healthcare Integrated IT Solutions · Radiology device
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Jun 2012
Decision
28d
Days
Class 2
Risk

K121387 is an FDA 510(k) clearance for the CENTRICITY PACS-IW. 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 Healthcare Integrated IT Solutions (Barrington, US). The FDA issued a Cleared decision on June 5, 2012 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Incremental AI imaging tool. Low regulatory complexity profile. 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 Healthcare Integrated IT Solutions devices

FDA 510(k) Submission Details - K121387

510(k) Number K121387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 08, 2012
Decision Date June 05, 2012
Days to Decision 28 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
79d faster than avg
Panel avg: 107d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 1204
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K121387.
SYNGO.MR NEUROLOGY
K121459 · Siemens Medical Solutions USA, Inc. · Jun 2012
SYNAPSE 3D LUNG AND ABDOMEN ANALYSIS
K120648 · Fujifilm Medical System U.S.A., Inc. · Jun 2012
SCENIUM 2.0
K121074 · Siemens Medical Solutions USA, Inc. · Jun 2012
SYNAPSE 3D NODULE ANALYSIS
K120679 · Fujifilm Medical Systems U.S.A, Inc. · Jun 2012
QLAB WITH FHN AND VPQ PLUG-IN
K121223 · Philips Ultrasound, Inc. · May 2012
SYNAPSE 3D BRAIN PERFUSION
K120637 · Fujifilm Medical System U.S.A., Inc. · May 2012