Cleared Traditional

K181460 - OnePacs System

K181460 is the FDA 510(k) clearance for OnePacs System by Onepacs, LLC. It is a Class 2 Radiology device (product code LLZ) cleared through the Traditional 510(k) pathway after a 129-day FDA review.

K181460 · Onepacs, LLC · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2018
Decision
129d
Days
Class 2
Risk

K181460 is an FDA 510(k) clearance for the OnePacs System. 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 Onepacs, LLC (Palo Alto, US). The FDA issued a Cleared decision on October 11, 2018 after a review of 129 days - within the typical 510(k) review window.

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 Onepacs, LLC devices

Submission Details

510(k) Number K181460 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 2018
Decision Date October 11, 2018
Days to Decision 129 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
22d slower than avg
Panel avg: 107d · This submission: 129d
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 1055
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K181460.
JiveX
K181964 · Visus Health IT GmbH · Oct 2018
UroNav (Version 3.0)
K182561 · Invivo Corporation · Oct 2018
Arterys MICA
K182034 · Arterys, Inc. · Oct 2018
Ziostation2
K181892 · Ziosoft, Inc. · Oct 2018
Synapse 3D Optional Tools
K181773 · Fujifilm Corporation · Sep 2018
IBM iConnect Access
K182290 · Merge Healthcare Incorporated · Sep 2018