Cleared Traditional

IMAGEGRID RADIOLOGY VIEWER SYSTEM (K092949) - FDA 510(k) Clearance

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

K092949 · Candelis, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2009
Decision
14d
Days
Class 2
Risk

K092949 is an FDA 510(k) clearance for the IMAGEGRID RADIOLOGY VIEWER 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 Candelis, Inc. (Denton, US). The FDA issued a Cleared decision on October 8, 2009 after a review of 14 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 Candelis, Inc. devices

Submission Details

510(k) Number K092949 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2009
Decision Date October 08, 2009
Days to Decision 14 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
93d faster than avg
Panel avg: 107d · This submission: 14d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 732
Devices cleared under the same product code (LLZ) and FDA review panel - the closest regulatory comparables to K092949.
SYMBIA.NET, SYMBIA.NET SELECT MODEL 10520828, 10520827
K100619 · Siemens Medical Solutions USA, Inc. · May 2010
STORM-BASE 2.0
K093603 · KARL STORZ Endoscopy-America, Inc. · Mar 2010
SYNGO.PET&CT ONCOLOGY
K093621 · Siemens Medical Solutions USA, Inc. · Feb 2010
SYNGO TRUED
K091373 · Siemens Medical Solutions USA, Inc. · May 2009
SYNGOCIRCULATION DYNAMICPET, VERSION 1.0
K083327 · Siemens Medical Solutions USA, Inc. · May 2009
SYNGO US WORKPLACE
K091286 · Siemens Medical Solutions USA, Inc. · May 2009