STAGE REF 200008

GUDID 00866463000465

STAGE is a MR post-processing software medical device intended for use in the visualization of the brain. STAGE analyzes input data from MR imaging systems. STAGE runs within a VM environment on hardware that meets the minimum requirements. STAGE utilizes magnitude and phase data acquired with specific parameters to generate enhanced T1 weighted images, SWI images, susceptibility enhanced images, pseudo-susceptibility maps, true SWI images, MR angiography (MRA) images, simulated T2 images, simulated T2 FLAIR images, simulated dual inversion recovery (DIR) images, and maps of T1, R2*, and proton density (PD). CROWN, introduced in STAGE, reduces noise some of these outputs, enhancing SNR and/or reducing imaging time. STAGE is indicated for brain imaging. Maximum and minimum intensity projections of some of these outputs will also be provided. The STAGE outputs can be configured to match the conventional acquisition series in MR protocols (i.e. routine brain w/) in terms of contrast, orientation and resolution. STAGE should always be used in combination with at least one other conventional MR acquisition technique (e.g. T2 FLAIR). STAGE input data can be acquired within a range of collection parameters, within shorter echo acquisitions allowing for less susceptibility affects and higher anatomic signal at the air tissue interface or with longer echo times for higher susceptibility effects around blood products and iron sources.

Spintech, Inc.

MRI system application software

• Primary Device ID: 00866463000465
• NIH Device Record Key: 5e907f6c-a818-4371-8acc-0312f2aefe32
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: STAGE
• Version Model Number: 2.3
• Catalog Number: REF 200008
• Company DUNS: 105125594
• Company Name: Spintech, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +2487126789
• Email: rana@spintechmri.com
• Phone: +2487126789
• Email: rana@spintechmri.com
• Phone: +2487126789
• Email: rana@spintechmri.com
• Phone: +2487126789
• Email: rana@spintechmri.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00866463000465 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K223079

FDA Product Code

• LLZ: System, Image Processing, Radiological

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2025-04-04
• Device Publish Date: 2025-03-27

On-Brand Devices [STAGE]

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