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OnePacs System

by Onepacs, LLC

510(k) K181460

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK181460 Date11 Oct 2018ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LLZ
Device Class
Class II
Regulation
21 CFR Part 892.2050
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The OnePacs System is a cloud-based picture archiving and communications system (PACS) for medical imaging and data management. It is designed to streamline radiology workflows, boost accuracy, and support fast, secure image sharing. The system is intended for use in teleradiology practices, imaging centers, hospitals, and healthcare systems.

The OnePacs System is supplied by Onepacs, LLC and received FDA 510(k) clearance on October 11, 2018, with K number K181460. It is a cloud-based system that provides secure access to reduce delays in medical imaging. The device is not specified as single-use or reusable, and no MRI safety information is provided in the data.