IMAGE DIAGNOSTICS, INC

Basic Information

• Brand Name: IMAGE DIAGNOSTICS, INC
• Primary DI: 00850061871183
• Version / Model: Protego ProLite System for Siemens Artis Tables
• Catalog Number: A800-0471-SIA
• Company Name: IMAGE DIAGNOSTICS, INC.
• Labeler DUNS: 608235214
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-04-29
• Public Version: 1
• Public Version Date: 2025-05-07
• Public Version Status: New
• Public Device Record Key: d5b66a30-7eb6-4722-9c38-b53bbc3327c8

Device Description

IDI,RADIATION SHIELD SYSTEM,PROTEGO,PROLITE TABLE MOUNT,METRIC ACCESSORY RAILS,SIEMENS ARTIS TABLE#A800-0471-SIA

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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
IWQ	Curtain, Protective, Radiographic	Radiology	892.6500	1

GMDN Terms

Code	Name	Definition	Implantable	Status
38375	Radiation shielding curtain	A flexible radiation protective device intended to shield the operator or other attending persons from unnecessary exposure to radiation emitted during a medical or dental procedure. The curtain is a flexible radiation blocking or attenuating barrier located between the individual and the source of primary or scattered radiation. This radiation barrier is designed to hang from rods or tracks attached to the ceiling, wall, radiation delivery equipment, or other radiation shields. It typically consists of a fluid resistant outer covering that surrounds a thin sheet of flexible lead (Pb) or lead-equivalent material.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00850061871183	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]