TrueView

GUDID 06974970580081

The TrueView Core 100Pro-US Core Specimen Radiography System (CSRS) is a Cabinet X-ray System intended to provide the detailed radiographic imaging of small surgical excised or biopsy specimens and to further provide rapid verification that correct tissue has been excised.

CompAI Healthcare (Suzhou) Co.,ltd

Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD Tissue specimen x-ray system IVD
Primary Device ID06974970580081
NIH Device Record Keyd332857f-1a94-4ab7-bc8b-15c29e04ab41
Commercial Distribution StatusIn Commercial Distribution
Brand NameTrueView
Version Model NumberCore 100Pro-US
Company DUNS554545203
Company NameCompAI Healthcare (Suzhou) Co.,ltd
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

Device Identifiers

Device Issuing AgencyDevice ID
GS106974970580081 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

MWPCabinet, X-Ray System

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-05-25
Device Publish Date2023-05-17

On-Brand Devices [TrueView]

06974970580081The TrueView Core 100Pro-US Core Specimen Radiography System (CSRS) is a Cabinet X-ray System in
06974970580074The TrueView 200 Pro-US is a Cabinet X-ray System intended to provide the detailed radiographic

Trademark Results [TrueView]

Mark Image

Registration | Serial
Company
Trademark
Application Date
TRUEVIEW
TRUEVIEW
98391031 not registered Live/Pending
LX Hausys, Ltd.
2024-02-05
TRUEVIEW
TRUEVIEW
98391029 not registered Live/Pending
LX Hausys, Ltd.
2024-02-05
TRUEVIEW
TRUEVIEW
98157093 not registered Live/Pending
Ecolab USA Inc.
2023-08-30
TRUEVIEW
TRUEVIEW
98084112 not registered Live/Pending
Otto, LLC
2023-07-13
TRUEVIEW
TRUEVIEW
97463436 not registered Live/Pending
Barcodes, LLC
2022-06-17
TRUEVIEW
TRUEVIEW
97326359 not registered Live/Pending
Solid Start, Inc.
2022-03-23
TRUEVIEW
TRUEVIEW
90651595 not registered Live/Pending
TALEX Co., Ltd.
2021-04-16
TRUEVIEW
TRUEVIEW
88817289 not registered Live/Pending
Top Gun Technology, Inc.
2020-03-02
TRUEVIEW
TRUEVIEW
88714335 not registered Live/Pending
Great Plains Manufacturing, Incorporated
2019-12-04
TRUEVIEW
TRUEVIEW
88466444 5937970 Live/Registered
Fortem Technologies, Inc.
2019-06-10
TRUEVIEW
TRUEVIEW
88141723 not registered Live/Pending
iXsystems, Inc.
2018-10-03
TRUEVIEW
TRUEVIEW
88122242 not registered Live/Pending
GOOGLE LLC
2018-09-18

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