APELEM

GUDID 03760172650447

Remote controlled Radiology System

APELEM

Basic diagnostic x-ray system table, powered Basic diagnostic x-ray system table, powered Basic diagnostic x-ray system table, powered Basic diagnostic x-ray system table, powered Basic diagnostic x-ray system table, powered Basic diagnostic x-ray system table, powered Basic diagnostic x-ray system table, powered Basic diagnostic x-ray system table, powered Basic diagnostic x-ray system table, powered Basic diagnostic x-ray system table, powered Basic diagnostic x-ray system table, powered Basic diagnostic x-ray system table, powered Basic diagnostic x-ray system table, powered Basic diagnostic x-ray system table, powered Basic diagnostic x-ray system table, powered Basic diagnostic x-ray system table, powered

• Primary Device ID: 03760172650447
• NIH Device Record Key: 1111517d-c84e-47c7-a15c-74f1496cbfde
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: APELEM
• Version Model Number: PLATINUM dRF (8L)
• Company DUNS: 268596533
• Company Name: APELEM
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	03760172650447 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K203010

FDA Product Code

• JAA: System, X-Ray, Fluoroscopic, Image-Intensified

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: 2023-06-15
• Device Publish Date: 2023-06-07

On-Brand Devices [APELEM]

• 03760172650430: Remote controlled radiology system
• 03760172650003: Remote controlled radiology system
• 03760172650508: Remote Controlled Radiology System
• 03760172650485: Remote Controlled Radiology System
• 03760172650447: Remote controlled Radiology System
• 03760172650409: Remote Controlled Radiology System