MLCL Client Software 5973597

GUDID 00195278931504

Software Medical Device GE Client Software V9.0

Ge Medical Systems Information Technologies, Inc.

Cardiac electrophysiology analysis system

• Primary Device ID: 00195278931504
• NIH Device Record Key: c3534814-c21b-4d17-a0e0-123d26dc5424
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: MLCL Client Software
• Version Model Number: AltiX AI.i
• Catalog Number: 5973597
• Company DUNS: 118935631
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00195278931504 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K243540

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: 2025-05-13
• Device Publish Date: 2025-05-05

On-Brand Devices [MLCL Client Software]

• 00195278507525: Software Medical Device GE Client Software V8.0
• 00195278931504: Software Medical Device GE Client Software V9.0