SoftVue 900-00035

GUDID 00860000221306

SoftVue™ Automated Whole Breast Ultrasound System With Sequr™ Breast Interface Assembly

Delphinus Medical Technologies, Inc

Breast ultrasound imaging system
Primary Device ID00860000221306
NIH Device Record Keyad796bcb-7265-45c2-a0b0-a72e62706af6
Commercial Distribution StatusIn Commercial Distribution
Brand NameSoftVue
Version Model NumberAtlantic
Catalog Number900-00035
Company DUNS963425017
Company NameDelphinus Medical Technologies, Inc
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1 (844) 763-8883
Emailservice@delphinusmt.com
Phone1 (844) 763-8883
Emailservice@delphinusmt.com
Phone1 (844) 763-8883
Emailservice@delphinusmt.com
Phone1 (844) 763-8883
Emailservice@delphinusmt.com

Operating and Storage Conditions

Storage Environment TemperatureBetween 5 Degrees Celsius and 43 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween 5 Degrees Celsius and 43 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween 5 Degrees Celsius and 43 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar
Storage Environment TemperatureBetween 5 Degrees Celsius and 43 Degrees Celsius
Storage Environment HumidityBetween 10 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
Storage Environment Atmospheric PressureBetween 700 millibar and 1060 millibar

Device Identifiers

Device Issuing AgencyDevice ID
GS100860000221306 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

PAAAutomated Breast Ultrasound

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-12-15
Device Publish Date2022-12-07

Trademark Results [SoftVue]

Mark Image

Registration | Serial
Company
Trademark
Application Date
SOFTVUE
SOFTVUE
87043815 not registered Live/Pending
Delphinus Medical Technologies, Inc.
2016-05-19
SOFTVUE
SOFTVUE
74514735 not registered Dead/Abandoned
O.S.I. Corporation
1994-04-15

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