MUSE

GUDID 00195278458070

MUSE NX R2 SOFTWARE

GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, INC.

Cardiology information system application software

• Primary Device ID: 00195278458070
• NIH Device Record Key: 8807cb72-d4af-4441-8d24-adf8d6127ca8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MUSE
• Version Model Number: NX R2
• Company DUNS: 006580799
• Company Name: GE MEDICAL SYSTEMS INFORMATION TECHNOLOGIES, 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: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195278458070 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152993

FDA Product Code

• DQK: Computer, diagnostic, programmable

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: 2022-11-18
• Device Publish Date: 2022-11-10

On-Brand Devices [MUSE]

• 00840682142809: NX
• 00840682100182: v9
• 00195278458070: MUSE NX R2 SOFTWARE