Cleared Traditional

K200974 - QLAB Advanced Quantification Software

K200974 is the FDA 510(k) clearance for QLAB Advanced Quantification Software by Philips Health Care. It is a Class 2 Radiology device (product code QIH) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K200974 · Philips Health Care · Radiology device
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Jun 2020
Decision
51d
Days
Class 2
Risk

K200974 is an FDA 510(k) clearance for the QLAB Advanced Quantification Software. Classified as Automated Radiological Image Processing Software within the QIH classification (a category dominated by AI-based automated radiology processing systems), Class II - Special Controls.

Submitted by Philips Health Care (Bothell, US). The FDA issued a Cleared decision on June 3, 2020 after a review of 51 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 Philips Health Care devices

Submission Details

510(k) Number K200974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2020
Decision Date June 03, 2020
Days to Decision 51 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
56d faster than avg
Panel avg: 107d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QIH Automated Radiological Image Processing Software
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.2050
Definition To Provide Automated Radiological Image Processing And Analysis Tools. Software Implementing Artificial Intelligence Including Nonadaptive Machine Learning Algorithms Trained With Clinical And/or Artificial Data. In These Devices, The Algorithm Training Data Typically Impacts Device Performance. Adaptive Ai Algorithms Are Not Within Scope Of This Product Code.
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 - QIH Automated Radiological Image Processing Software

All 297
Devices cleared under the same product code (QIH) and FDA review panel - the closest regulatory comparables to K200974.
Ezra Plexo Software
K192969 · Ezra Ai, Inc. · Jul 2020
LVivo Software Application
K200232 · Dia Imaging Analysis, Ltd. · Jun 2020
MEDO ARIA
K200356 · Medo.Ai · Jun 2020
uWS-MR
K192601 · Shanghai United Imaging Healthcare Co., Ltd. · Jun 2020
Arterys MICA
K192437 · Arterys, Inc. · Mar 2020
QLAB Advanced Quantification Software
K191647 · Philips Health Care · Dec 2019