Selenia Dimensions (UDI ASY-10775)
Manufactured by Hologic, Inc.
Device Regulatory Overview
The Selenia Dimensions (Model/Catalog Number: ASY-10775) is a medical device manufactured by Hologic, Inc.. This product is indexed under FDA Product Code / Category Classification MUE within international Unique Device Identification (UDI) compliance databases.
Enforcement actions are currently active for this product line.
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Technical Specifications
- Model Number
- ASY-10775
- Product Code / EMDN
- MUE
- Device Name
- Selenia Dimensions digital mammography system generates digital mammographic images that can be used for screening and diagnosis of breast cancer.
- Database Sync Date
- 2026-08-09 09:22:50
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 Selenia Dimensions?
The registered manufacturer of record for Selenia Dimensions is Hologic, Inc..
What is the Primary UDI-DI identifier for Selenia Dimensions?
The Primary UDI-DI identifier registered in FDA GUDID and EUDAMED records is ASY-10775.
What classification code is assigned to this device?
This device is registered under product classification code MUE.
Similar Classification Devices (MUE)
Other Devices by Hologic, Inc.
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