SKANMOBILE

GUDID 08904269403522

Skanmobile is a high frequency Mobile X-Ray System for diagnostic radiography. The system houses two microprocessors, one for control / supervisory functions and another for man-machine/user interface. The technology incorporates feedback circuits to ensure accuracy & reproducibility of X-Ray output.

SKANRAY TECHNOLOGIES LIMITED

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• Primary Device ID: 08904269403522
• NIH Device Record Key: 714d6ac5-108b-4754-b043-c00c45dfd317
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SKANMOBILE
• Version Model Number: 303-000018-3
• Company DUNS: 863358955
• Company Name: SKANRAY TECHNOLOGIES LIMITED
• 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	08904269403522 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K212940

FDA Product Code

• IZL: System, X-Ray, Mobile

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: 2022-04-29
• Device Publish Date: 2022-04-21

Devices Manufactured by SKANRAY TECHNOLOGIES LIMITED

• 08904269415105 - PodSKAN HF Diagnostic X-ray System: 2024-01-01 PodSKAN is an advanced high frequency type X-Ray system designed for superior image quality with powerful 2.8KW generator and ve
• 08904269409531 - SKANRAD 400: 2022-05-19 Skanrad 400 is an advanced high frequency type X-ray system designed for superior image quality for radiographic use with powerf
• 08904269403522 - SKANMOBILE: 2022-04-29Skanmobile is a high frequency Mobile X-Ray System for diagnostic radiography. The system houses two microprocessors, one for control / supervisory functions and another for man-machine/user interface. The technology incorporates feedback circuits to ensure accuracy & reproducibility of X-Ray output.
• 08904269403522 - SKANMOBILE: 2022-04-29 Skanmobile is a high frequency Mobile X-Ray System for diagnostic radiography. The system houses two microprocessors, one for co
• 08904269403683 - SKANMOBILE DR: 2022-04-29 SKANMOBILE DR is a digital radiographic system designed for superior image quality featuring wireless flat panel detector and op
• 08904269405519 - Skan C Mobile C - Arm X - Ray system: 2022-01-19 SKAN-C, is a mobile X-Ray C-Arm fluoroscopic device to assist in guiding medical intervention surgical procedures. The device ca