gudid
Primary ID: 91365
Standard Imaging IMSure 3D (UDI 91365)
Manufactured by STANDARD IMAGING INC.
Data verified against official FDA/EUDAMED records on
Scannable UDI-DI Representation
GS1-128 UDI Barcode representation for Standard Imaging IMSure 3D - Primary ID 91365
Device Regulatory Overview
The Standard Imaging IMSure 3D (Model/Catalog Number: 91365) is a medical device manufactured by STANDARD IMAGING INC.. This product is indexed under FDA Product Code / Category Classification IYE within international Unique Device Identification (UDI) compliance databases.
Technical Specifications
- Model Number
- 91365
- Product Code / EMDN
- IYE
- Device Name
- Standard Imaging IMSure 3D (IM3D) QA software is intended to be used for radiation dose calculation and radiation treatment plan quality assurance in radiation therapy.
- Database Sync Date
- 2026-08-09 09:37:45
Full Regulatory Attributes
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{
"review_panel": "AN",
"gudid_di_status": "Published",
"sterilization_methods": ["EO", "Gamma"],
"rx_only": true
}
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Get API Token Access ($49/mo)Frequently Asked Questions
Who is the primary manufacturer of Standard Imaging IMSure 3D?
The registered manufacturer of record for Standard Imaging IMSure 3D is STANDARD IMAGING INC..
What is the Primary UDI-DI identifier for Standard Imaging IMSure 3D?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is 91365.
What classification code is assigned to this device?
This device is registered under product classification code IYE.
Similar Classification Devices (IYE)
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