STAGE

GUDID 00866463000441

STAGE works as a comprehensive brain imaging post-processing solution. The STAGE system consists of a client supplied dedicated computer with an ethernet connection to the client’s existing local network. The STAGE software will operate within a virtual machine environment (virtual STAGE module) on this dedicated computer. The computer receives DICOM data from a specific MRI 3D GRE scan protocol (i.e., the STAGE protocol) and then outputs back numerous DICOM datasets with different types of contrast to the PACS server. The data transfer is initiated by the user’s current DICOM viewing software. STAGE has been modified from the predicate to include CROWN, a white noise filtering algorithm intended to improve specific STAGE outputs. The following table provide a summary of the methodology for each output with an example image and technical comparison to the predicate.

Spintech, Inc.

MRI system application software
Primary Device ID00866463000441
NIH Device Record Key03e28d69-4eb2-4224-8df4-e8fac407cf8c
Commercial Distribution StatusIn Commercial Distribution
Brand NameSTAGE
Version Model Number2
Company DUNS105125594
Company NameSpintech, 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 Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone2487126789
Emailinfo@spintechmri.com
Phone2487126789
Emailinfo@spintechmri.com
Phone2487126789
Emailinfo@spintechmri.com
Phone2487126789
Emailinfo@spintechmri.com
Phone2487126789
Emailinfo@spintechmri.com
Phone2487126789
Emailinfo@spintechmri.com
Phone2487126789
Emailinfo@spintechmri.com
Phone2487126789
Emailinfo@spintechmri.com
Phone2487126789
Emailinfo@spintechmri.com
Phone2487126789
Emailinfo@spintechmri.com
Phone2487126789
Emailinfo@spintechmri.com
Phone2487126789
Emailinfo@spintechmri.com
Phone2487126789
Emailinfo@spintechmri.com
Phone2487126789
Emailinfo@spintechmri.com
Phone2487126789
Emailinfo@spintechmri.com
Phone2487126789
Emailinfo@spintechmri.com
Phone2487126789
Emailinfo@spintechmri.com
Phone2487126789
Emailinfo@spintechmri.com
Phone2487126789
Emailinfo@spintechmri.com
Phone2487126789
Emailinfo@spintechmri.com
Phone2487126789
Emailinfo@spintechmri.com
Phone2487126789
Emailinfo@spintechmri.com
Phone2487126789
Emailinfo@spintechmri.com
Phone2487126789
Emailinfo@spintechmri.com
Phone2487126789
Emailinfo@spintechmri.com
Phone2487126789
Emailinfo@spintechmri.com
Phone2487126789
Emailinfo@spintechmri.com
Phone2487126789
Emailinfo@spintechmri.com
Phone2487126789
Emailinfo@spintechmri.com
Phone2487126789
Emailinfo@spintechmri.com
Phone2487126789
Emailinfo@spintechmri.com
Phone2487126789
Emailinfo@spintechmri.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100866463000441 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

LNHSystem, Nuclear Magnetic Resonance Imaging

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-03-03
Device Publish Date2023-02-23

On-Brand Devices [STAGE]

00866463000410STAGE works as a comprehensive brain imaging post-processing solution. The STAGE system consists
00866463000441STAGE works as a comprehensive brain imaging post-processing solution. The STAGE system consists
00866463000465STAGE is a MR post-processing software medical device intended for use in the visualization of t

Trademark Results [STAGE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
STAGE
STAGE
98733311 not registered Live/Pending
Riedel Communications International GmbH
2024-09-04
STAGE
STAGE
98594666 not registered Live/Pending
Stage, LLC
2024-06-11
STAGE
STAGE
98537458 not registered Live/Pending
Odyssey Space Research, LLC
2024-05-07
STAGE
STAGE
98478741 not registered Live/Pending
Belkin International, Inc.
2024-04-01
STAGE
STAGE
97215690 not registered Live/Pending
Stage Technologies, Inc.
2022-01-12
STAGE
STAGE
90705487 not registered Live/Pending
Virginia Carnesale
2021-05-12
STAGE
STAGE
90654086 not registered Live/Pending
Virginia Carnesale
2021-04-19
STAGE
STAGE
88522570 not registered Live/Pending
Cirkul, Inc.
2019-07-18
STAGE
STAGE
88302853 not registered Live/Pending
Drew Layne, LLC
2019-02-15
STAGE
STAGE
87888324 5626952 Live/Registered
Tower Of Quarters, Inc.
2018-04-23
STAGE
STAGE
87647540 not registered Dead/Abandoned
DATA CENTER STANDARDS FOUNDATION
2017-10-16
STAGE
STAGE
87647528 not registered Dead/Abandoned
DATA CENTER STANDARDS FOUNDATION
2017-10-16
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