iQ-SYSTEM PACS

Basic Information

• Brand Name: iQ-SYSTEM PACS
• Primary DI: B403IQS11004
• Version / Model: 1.10
• Company Name: IMAGE Information Systems Europe GmbH
• Labeler DUNS: 341050957
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2026-02-19
• Public Version: 1
• Public Version Date: 2026-02-27
• Public Version Status: New
• Public Device Record Key: 1ef81afe-759e-409a-8678-30af5fc89e68

Device Description

iQ-SYSTEM PACS is a software for network or web-based medical image viewing and manipulation. It is adapted for storing, processing, routing and reporting.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LLZ	System, Image Processing, Radiological	Radiology	892.2050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
41669	Radiology picture archiving and communication system digital archive device	A mains electricity (AC-powered) device, typically a component of a picture archiving and communication system (PACS), used for the storage and retrieval of digital radiological images and information about the images. Its integral software functions as a database for the storage and management of the radiological images and information contained therein.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B403IQS11004	HIBCC

Premarket Submissions

Submission Number	Supplement Number
K062488	000