AccessGUDID - DEVICE: SoftVue (00860000221306)

GUDID

Device Identifier (DI) Information

Brand Name: SoftVue
Version or Model: Atlantic
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 900-00035
Company Name: Delphinus Medical Technologies, Inc

Primary DI Number: 00860000221306
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 963425017 *Terms of Use

Device Description: SoftVue™ Automated Whole Breast Ultrasound System With Sequr™ Breast Interface Assembly

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?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PAA	Automated Breast Ultrasound

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
P200040	000

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
Storage Environment Temperature: between 5 and 43 Degrees Celsius
Storage Environment Humidity: between 10 and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 700 and 1060 millibar

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: ad796bcb-7265-45c2-a0b0-a72e62706af6
Public Version Date: December 15, 2022
Public Version Number: 1
DI Record Publish Date: December 07, 2022