ECTphan™

Basic Information

• Brand Name: ECTphan™
• Primary DI: 00812266030604
• Version / Model: SMR330SR
• Catalog Number: SMR330SR
• Company Name: Providus Holdings, Inc.
• Labeler DUNS: 104162493
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-03-11
• Public Version: 1
• Public Version Date: 2024-03-19
• Public Version Status: New
• Public Device Record Key: e9b62178-d95b-4cd3-9efa-f7cc9e9f9117

Device Description

ECTphan™ 330SR, Complete ECTphan™ including uniformity inserts and cantilever case mounting system

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: 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
IXF	Test-Pattern, Radiographic	Radiology	892.1940	1

GMDN Terms

Code	Name	Definition	Implantable	Status
40616	Multi-modality diagnostic imaging phantom, test object	A device that consists of a uniform density or a two or three-dimensional (3-D) pattern of objects, materials or openings of varying dimensions. It includes phantoms that come in both fixed and variable configurations and is a quality assurance device used in both subjective and quantitative evaluations of various calibration and performance characteristics of diagnostic imaging systems. A multi-modality phantom is specifically intended for use with more than one diagnostic imaging modality, e.g., magnetic resonance imaging (MRI), ultrasound, x-ray and nuclear medicine (NM) systems.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	00812266030604	GS1