AccessGUDID - DEVICE: Selenia® Dimensions® (15420045517639)

GUDID

Device Identifier (DI) Information

Brand Name: Selenia® Dimensions®
Version or Model: SDA-SYS-3000-2D-BR
Commercial Distribution Status: In Commercial Distribution
Catalog Number: SDA-SYS-3000-2D-BR
Company Name: Hologic, Inc.

Primary DI Number: 15420045517639
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 964430230 *Terms of Use

Device Description: Hologic Selenia Dimensions Avia 3000 package for 2D screening mammography or optional 2D diagnostic.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
37672	Stationary mammographic x-ray system, digital	A stationary assembly of devices designed to generate x-ray images of the breast using digital techniques for image capture and display. It is designed specifically to compress the breast during imaging and is intended to visually evaluate the anatomy and function of blood and lymphatic vessels within the breast. Often referred to as a digital mammography system (DMS) it is typically used for breast cancer screening or during biopsy procedures (e.g., placement of biopsy markers, stereotactic biopsy). It is designed to capture two-dimensional (2-D) x-ray images, however may include software intended to process multiple images to create a three-dimensional (3-D) image/model (tomosynthesis).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
OTE	Digital breast tomosynthesis

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P080003	000
P080003	010

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: a8d9bbcd-8ed6-4df7-b8ca-771b01bc5e90
Public Version Date: May 26, 2025
Public Version Number: 1
DI Record Publish Date: May 16, 2025