SonoCine Image Acquisition Station

Basic Information

• Brand Name: SonoCine Image Acquisition Station
• Primary DI: B3015017750001
• Version / Model: Model 201
• Catalog Number: 501775000
• Company Name: SONOCINE, INC.
• Labeler DUNS: 003555741
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-23
• Public Version: 4
• Public Version Date: 2021-05-10
• Public Version Status: Update
• Public Device Record Key: 568b6f18-2ad9-4f1f-b2ad-a4eb3821aecc

Device Description

SonoCiné Image Acquisition Station Model 201, PN 501775000 is an accessory to ultrasound imaging Systems facilitating their use as an adjunct to mammography for B-mode ultrasonic screening imaging of the breast when used with a linear array transducer consisting of the following components: Image Acquisition Station Model 201 – PN 501775-000, Image Acquisition Station Software Application V3.1.x, PN 501642, Reading Station Software Application, V3.1.x, PN 501973.

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• 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: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• 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
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	892.1560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40764	Breast ultrasound imaging system	An assembly of electrically-powered devices designed for extracorporeal and/or intracorporeal (endosonography or endoscopic) ultrasound imaging procedures involving the breast. It typically includes special imaging tables used to optimize the ability to give reproducible images of the breast. It typically includes software packages that support a variety of static or real-time breast specific imaging used primarily for oncology. It will generate ultrasound pulses, direct them to the target area, detect the ultrasound echoes, and process the resulting information to produce and display static or dynamic two- or three-dimensional (3-D) images.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	B3015017750001	HIBCC

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K082543	000