Cleared Traditional

Arterys MICA (K182034) - FDA 510(k) Clearance

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

K182034 · Arterys, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2018
Decision
79d
Days
Class 2
Risk

K182034 is an FDA 510(k) clearance for the Arterys MICA. 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 Arterys, Inc. (San Francisco, US). The FDA issued a Cleared decision on October 17, 2018 after a review of 79 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 Arterys, Inc. devices

Submission Details

510(k) Number K182034 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2018
Decision Date October 17, 2018
Days to Decision 79 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
28d faster than avg
Panel avg: 107d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 799
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K182034.
PeekMed
K182464 · Peek Health, S.A. · Oct 2018
JiveX
K181964 · Visus Health IT GmbH · Oct 2018
UroNav (Version 3.0)
K182561 · Invivo Corporation · Oct 2018
OnePacs System
K181460 · Onepacs, LLC · Oct 2018
Ziostation2
K181892 · Ziosoft, Inc. · Oct 2018
Synapse 3D Optional Tools
K181773 · Fujifilm Corporation · Sep 2018