InteleHeart

GUDID B228INTELEHEART0

PACS Device

Les Systèmes Médicaux Intelerad Incorporée

Radiological PACS software

• Primary Device ID: B228INTELEHEART0
• NIH Device Record Key: 183ad3ea-cc3e-4052-8681-bdfbd52ad053
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InteleHeart
• Version Model Number: 9
• Company DUNS: 201138695
• Company Name: Les Systèmes Médicaux Intelerad Incorporée
• 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: 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
HIBCC	B228INTELEHEART0 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K152949

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: 2024-05-24
• Device Publish Date: 2024-05-16

Devices Manufactured by Les Systèmes Médicaux Intelerad Incorporée

• B228INTELEHEART0 - InteleHeart: 2024-05-24PACS Device
• B228INTELEHEART0 - InteleHeart: 2024-05-24 PACS Device
• B228INTELESHARE0 - InteleShare: 2024-05-24
• B228INTELEPACS0 - INTELEPACS: 2018-09-24