Cleared Traditional

CubeVue (K181962) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K181962 · Curvebeam, LLC · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2018
Decision
15d
Days
Class 2
Risk

K181962 is an FDA 510(k) clearance for the CubeVue. 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 Curvebeam, LLC (Warrington, US). The FDA issued a Cleared decision on August 7, 2018 after a review of 15 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 Curvebeam, LLC devices

Submission Details

510(k) Number K181962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 23, 2018
Decision Date August 07, 2018
Days to Decision 15 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
92d faster than avg
Panel avg: 107d · This submission: 15d
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

Third Party Review Group, LLC
Dave Yungvirt

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 799
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K181962.
Change Healthcare Enterprise Viewer
K181185 · Change Healthcare Canada Company · Aug 2018
IGTFusion
K180522 · Igi Technologies · Aug 2018
ONIS-PACS
K181318 · Digitalcore Co., Ltd. · Aug 2018
VirtuOst Vertebral Fracture Assessment
K171435 · O.N. Diagnostics, LLC · Aug 2018
miPlatform medical imaging suite v3.0 (miPlatform v3.0), miPlatform ZFP Viewer
K171977 · Hinacom Software and Technology, Ltd. · Aug 2018
Quantitative Total Extensible Imaging (QTxI)
K173444 · Aiq Solutions, Inc. · Jul 2018