Cleared Traditional

K040686 - M'ATH STD

K040686 is an FDA 510(k) clearance for M'ATH STD, manufactured by Intelligence IN Medical Technologies. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K040686 · Intelligence IN Medical Technologies · Radiology device
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Jul 2004
Decision
136d
Days
Class 2
Risk

K040686 is an FDA 510(k) clearance for the M'ATH STD. 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 Intelligence IN Medical Technologies (Hartland, US). The FDA issued a Cleared decision on July 30, 2004 after a review of 136 days - within the typical 510(k) review window.

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 Intelligence IN Medical Technologies devices

FDA 510(k) Submission Details - K040686

510(k) Number K040686 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 16, 2004
Decision Date July 30, 2004
Days to Decision 136 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
29d slower than avg
Panel avg: 107d · This submission: 136d
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 1517
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K040686.
LEONARDO SYNGO CARDIOLOGY WORKSTATION
K042203 · Siemens Medical Solutions USA, Inc. · Sep 2004
SECURVIEW DX SOFTCOPY WORKSTATION
K041555 · Hologic, Inc. · Aug 2004
FUJI MEDICAL CR CONSOLE, MODEL FLASH IIP
K041990 · Fujifilm Medical System U.S.A., Inc. · Aug 2004
UNDECIDED
K041484 · Siemens Medical Solutions USA, Inc. · Jul 2004
ORTHO-CMS
K041162 · Medis Medical Imaging Systems BV · Jul 2004
CAAS MRV
K041682 · Pie Medical Imaging BV · Jul 2004