Cleared Traditional

K140960 - PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM

K140960 is an FDA 510(k) clearance for PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM, manufactured by Hologic, Inc.. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K140960 · Hologic, Inc. · Radiology device
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Jun 2014
Decision
59d
Days
Class 2
Risk

K140960 is an FDA 510(k) clearance for the PICTURE ARCHIVING AND COMMUNICATIONS SYSTEM. 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 June 13, 2014 after a review of 59 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

FDA 510(k) Submission Details - K140960

510(k) Number K140960 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2014
Decision Date June 13, 2014
Days to Decision 59 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 107d · This submission: 59d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 1914
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K140960.
RADSPA
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BRIGHTMATTER PLANNING SOFTWARE
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CLEARVIEWHD
K140139 · Clearview Diagnostics, Inc. · May 2014