ASPIRE Cristalle Digital Breast Tomosynthesis Option

Basic Information

• Brand Name: ASPIRE Cristalle Digital Breast Tomosynthesis Option
• Primary DI: 04547410351316
• Version / Model: DR 3500 TOMO KIT V2.0 USA E
• Company Name: FUJIFILM CORPORATION
• Labeler DUNS: 713565195
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2017-02-03
• Public Version: 3
• Public Version Date: 2023-12-11
• Public Version Status: Update
• Public Device Record Key: efd4190e-d1b0-4b15-96e3-1b21f91650b1

Device Description

The Fujifilm ASPIRE Cristalle with Digital Breast Tomosynthesis (DBT) Option acquires and generates FFDM and DBT images.

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: No
• 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
OTE	Digital breast tomosynthesis	Unknown		3

GMDN Terms

Code	Name	Definition	Implantable	Status
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).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04547410351316	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
P160031	000