Cleared Traditional

K140797 - IPACS MEDICAL IMAGE MANAGEMENT SYSTEM

K140797 is an FDA 510(k) clearance for IPACS MEDICAL IMAGE MANAGEMENT SYSTEM, manufactured by Visbion Limited. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K140797 · Visbion Limited · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2014
Decision
256d
Days
Class 2
Risk

K140797 is an FDA 510(k) clearance for the IPACS MEDICAL IMAGE MANAGEMENT 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 Visbion Limited (Chertsey, Surrey, GB). The FDA issued a Cleared decision on December 12, 2014 after a review of 256 days - an extended review 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-to-high 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 Visbion Limited devices

FDA 510(k) Submission Details - K140797

510(k) Number K140797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 31, 2014
Decision Date December 12, 2014
Days to Decision 256 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
149d slower than avg
Panel avg: 107d · This submission: 256d
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 1236
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K140797.
TOMTEC-ARENA TTA2
K150122 · Tomtec Imaging Systems GmbH · Feb 2015
CAAS A-Valve
K143044 · Pie Medical Imaging BV · Feb 2015
IMPAX Agility
K142316 · Agfa Healthcare N.V. · Jan 2015
eSie Apps Suite
K143254 · Siemens Medical Solutions USA, Inc. · Dec 2014
Endovascular Stent Planning Software
K143079 · Vital Images, Inc. · Dec 2014
QUANTRA
K142037 · Hologic, Inc. · Oct 2014