Cleared Traditional

K111336 - EBW NM 2.0

K111336 is the FDA 510(k) clearance for EBW NM 2.0 by Philips Medical Systems (Cleveland), Inc.. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 12-day FDA review.

K111336 · Philips Medical Systems (Cleveland), Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2011
Decision
12d
Days
Class 2
Risk

K111336 is an FDA 510(k) clearance for the EBW NM 2.0. 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 (Cleveland), Inc. (San Jose, US). The FDA issued a Cleared decision on May 24, 2011 after a review of 12 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 (Cleveland), Inc. devices

Submission Details

510(k) Number K111336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2011
Decision Date May 24, 2011
Days to Decision 12 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
95d faster than avg
Panel avg: 107d · This submission: 12d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Underwriters Laboratories, Inc.
NED DEVINE

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LLZ System, Image Processing, Radiological

All 1094
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K111336.
HEARTNAVIGATOR RELEASE 1
K111245 · Philips Medical Systems Nederland B.V. · Jul 2011
VITREAVIEW SOFTWARE 6.1
K111892 · Vital Images, Inc. · Jul 2011
QLAB 8.1 QUANTIFICATION SOFTWARE
K110414 · Philips Ultrasound, Inc. · Jun 2011
SYNGO NEURO PBV-IR
K111052 · Siemens Medical Solutions USA, Inc. · May 2011
CENTRICITY PACS
K110875 · Ge Healthcare · May 2011
AW VOLUMESHARE 5 WITH ANGIOVIZ OPTION
K110834 · Ge Healthcare · Apr 2011