Lunar iDXA

GUDID 00840682117029

GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC

Bone absorptiometric x-ray system, dual-energy

• Primary Device ID: 00840682117029
• NIH Device Record Key: 02960696-3f38-4059-8b5e-3583ac8b3e2e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Lunar iDXA
• Version Model Number: F1
• Company DUNS: 078863378
• Company Name: GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC
• 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: true
• 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

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 50 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00840682117029 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K052581

FDA Product Code

• KGI: Densitometer, bone

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-28
• Device Publish Date: 2016-06-27

Devices Manufactured by GE MEDICAL SYSTEMS, ULTRASOUND & PRIMARY CARE DIAGNOSTICS, LLC

• 00195278680938 - LOGIQ: 2023-12-12 LOGIQ E10 R4 Console
• 00195278513014 - Venue Fit: 2022-07-08 Venue Fit R4 MD either eDelivery or physical
• 00195278516480 - Venue: 2022-07-08 Venue R4 final Assembly
• 00195278516497 - Venue Fit: 2022-07-08 Venue Fit R4 Final Assembly
• 00195278516534 - Venue: 2022-07-08 Venue R4 MD either eDelivery or physical
• 00195278516510 - Venue Go: 2022-07-05 Venue Go R4 Final Assembly
• 00195278516541 - Venue Go: 2022-07-05 Venue Go R4 MD either eDelivery or physical
• 00195278384041 - LOGIQ: 2021-11-23 LOGIQ E10 R3 Console