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ImageGrid Radiology Viewer System

by Candelis, Inc.

510(k) K092949

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

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK092949 Date8 Oct 2009ClearedStatusActive

Official records

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  • Withdrawn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

Related clearances

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 19 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 ImageGrid Radiology Viewer System is a medical imaging device designed for the reception, storage, communication, and display of digital medical images and data from various imaging modalities. It functions as a Picture Archiving and Communication System (PACS) to facilitate workflow optimization, enabling radiologists and clinicians to view, analyze, and share images across distributed networks.

This system is supplied as software and integrates with existing IT infrastructure to route, store, and present DICOM-compatible medical images. It is intended for use in radiology departments and clinical settings, where pre-processed DICOM presentation images—including mammography—can be interpreted for diagnostic purposes. The device is classified under FDA 510(k) clearance (K092949) with a traditional review pathway and is intended for single-use or multi-user networked environments, though sterility and reuse specifications are not explicitly detailed in the data.

Similar devices

Other devices filed under FDA product code LLZ (System, Image Processing, Radiological).

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