Cleared Traditional

K061372 - CENTRICITY AW SUITE OPTION

K061372 is an FDA 510(k) clearance for CENTRICITY AW SUITE OPTION, manufactured by Ge Healthcare Information Technologies. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K061372 · Ge Healthcare Information Technologies · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
13d
Days
Class 2
Risk

K061372 is an FDA 510(k) clearance for the CENTRICITY AW SUITE OPTION. 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 Information Technologies (Barrington, US). The FDA issued a Cleared decision on May 30, 2006 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 Ge Healthcare Information Technologies devices

FDA 510(k) Submission Details - K061372

510(k) Number K061372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2006
Decision Date May 30, 2006
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.

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 K061372.
5M MONOCHROME DIGITAL MAMMOGRAPHY LCD MONITOR MDL2116A (ME551I2)
K061447 · Totoku Electric Co., Ltd. · Jul 2006
SYNAPSE MIP/MPR IMAGE VISUALIZATION SOFTWARE OBLIQUUS
K061672 · Fujifilm Medical Systems U.S.A, Inc. · Jun 2006
VITREA, VERSION 3.9
K061624 · Vital Images, Inc. · Jun 2006
QLAB QUANTIFICATION SOFTWARE
K061396 · Philips Ultrasound, Inc. · May 2006
3MATIC
K060950 · Materialise NV · May 2006
15-INCH (38CM) COLOR LCD MONITOR CDL1566A
K060961 · Totoku Electric Co., Ltd. · May 2006