Cleared Traditional

K070831 - VOXAR 3D ENTERPRISE WITH COLONMETRIX AND PET/CT PERFUSION

K070831 is an FDA 510(k) clearance for VOXAR 3D ENTERPRISE WITH COLONMETRIX AN..., manufactured by Barcoview Mis Edinburgh. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K070831 · Barcoview Mis Edinburgh · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
57d
Days
Class 2
Risk

K070831 is an FDA 510(k) clearance for the VOXAR 3D ENTERPRISE WITH COLONMETRIX AND PET/CT PERFUSION. 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 Barcoview Mis Edinburgh (Edinburgh, Lothian, GB). The FDA issued a Cleared decision on May 22, 2007 after a review of 57 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 Barcoview Mis Edinburgh devices

FDA 510(k) Submission Details - K070831

510(k) Number K070831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2007
Decision Date May 22, 2007
Days to Decision 57 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
50d faster than avg
Panel avg: 107d · This submission: 57d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

LLZ Device Classification - Class 2, Special Controls

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 1368
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K070831.
IMAGE-ARENA APPLICATIONS AND RESEARCH-ARENA APPLICATIONS
K071232 · Tomtec Imaging Systems GmbH · Jun 2007
VITAL CONNECT 4.1
K071362 · Vital Images, Inc. · May 2007
VITREA VERSION 4.0
K071331 · Vital Images, Inc. · May 2007
SYNGO IMAGING (VERSION V30)
K071114 · Siemens AG Medical Solutions · May 2007
QLAB QUANTIFICATION
K070792 · Philips Ultrasound, Inc. · Apr 2007
NIO 5MP-21 AND MDNG-5121 CB
K062621 · Barcoview · Mar 2007