Cleared Special

K181177 - Interventional Workspot

K181177 is the FDA 510(k) clearance for Interventional Workspot by Philips Medical Systems Nederland B.V.. It is a Class 2 Radiology device (product code LLZ) cleared through the Special 510(k) pathway after a 29-day FDA review.

K181177 · Philips Medical Systems Nederland B.V. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2018
Decision
29d
Days
Class 2
Risk

K181177 is an FDA 510(k) clearance for the Interventional Workspot. 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 Nederland B.V. (Best Noord-Brabant, NL). The FDA issued a Cleared decision on May 31, 2018 after a review of 29 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Incremental AI imaging tool. Low regulatory complexity profile. 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 Nederland B.V. devices

Submission Details

510(k) Number K181177 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 2018
Decision Date May 31, 2018
Days to Decision 29 days
Submission Type Special
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
78d faster than avg
Panel avg: 107d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 1092
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K181177.
Fusion Bx 2.0
K181290 · Focal Healthcare, Inc. · Jun 2018
EchoMD Automated Ejection Fraction Software
K173780 · Bay Labs, Inc. · Jun 2018
QLAB Advanced Quantification Software
K181264 · Philips Ultrasound, Inc. · Jun 2018
McKesson Cardiology
K181080 · Change Healthcare Israel , Ltd. · May 2018
5D Viewer
K180883 · Samsung Medison Co., Ltd. · May 2018
Invenia ABUS Viewer
K180641 · Ge Healthcare · May 2018