Cleared Traditional

K994210 - INTURIS SUITE

K994210 is the FDA 510(k) clearance for INTURIS SUITE by Philips Medical Systems, Inc.. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K994210 · Philips Medical Systems, Inc. · Radiology device
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Feb 2000
Decision
52d
Days
Class 2
Risk

K994210 is an FDA 510(k) clearance for the INTURIS SUITE. 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 Philips Medical Systems, Inc. (Shelton, US). The FDA issued a Cleared decision on February 4, 2000 after a review of 52 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 Medical Systems, Inc. devices

Submission Details

510(k) Number K994210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 14, 1999
Decision Date February 04, 2000
Days to Decision 52 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
55d faster than avg
Panel avg: 107d · This submission: 52d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 1127
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K994210.
BARCOMED 5MP2
K000016 · Barco N.V. · Mar 2000
PEGASYS ULTRA
K993946 · Adac Laboratories · Mar 2000
BARCOMED 2MP2
K000015 · Barco N.V. · Feb 2000
PHILIPS INTURIS DICOM RECORDER
K993227 · Philips Medical Systems North America, Inc. · Dec 1999
AX WORKSTATION DR-VIEWER SOFTWARE OPTION
K992925 · Siemens Corp. · Nov 1999
POWERVIEW ULTRASOUND WORKSTATION, UIDM-400A
K992886 · Toshiba America Medical Systems, In.C · Nov 1999