Cleared Traditional

K083491 - NEUROSCAPE

K083491 is an FDA 510(k) clearance for NEUROSCAPE, manufactured by Olea Medical. The device is a Class 2 Radiology device with product code LLZ cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K083491 · Olea Medical · Radiology device
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Feb 2009
Decision
86d
Days
Class 2
Risk

K083491 is an FDA 510(k) clearance for the NEUROSCAPE. 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 Olea Medical (Austin, US). The FDA issued a Cleared decision on February 19, 2009 after a review of 86 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 Olea Medical devices

FDA 510(k) Submission Details - K083491

510(k) Number K083491 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2008
Decision Date February 19, 2009
Days to Decision 86 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
21d faster than avg
Panel avg: 107d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 2129
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K083491.
VISIX IMAGING
K082623 · Televere Systems · Feb 2009
BONEVUE
K083691 · Micromri, Inc. · Feb 2009
RESOLUTIONMD, RELEASE 2.1
K082693 · Calgary Scientific, Inc. · Feb 2009
MAMMODIAGNOST VU
K083740 · Philips Medical Systems Nederland B.V. · Feb 2009
SICAT IMPLANT
K090119 · Sicat GmbH & Co. KG · Feb 2009
CADSTREAM, VERSION 5.0
K081556 · Confirma, Inc. · Feb 2009