PodSKAN HF Diagnostic X-ray System

GUDID 08904269415105

PodSKAN is an advanced high frequency type X-Ray system designed for superior image quality with powerful 2.8KW generator and very low leakage radiation. The system houses two microprocessors, one for control/supervisory functions and another one man-machine/User interface. It can be easily plugged into 16A Wall socket with 120 VAC or 240 VAC, 50/60 Hz.. The technology incorporates feedback circuits to ensure highest accuracy & reproducibility of X-Ray output.

SKANRAY TECHNOLOGIES LIMITED

Stationary basic diagnostic x-ray system, digital

• Primary Device ID: 08904269415105
• NIH Device Record Key: 5602a890-54c1-473d-9ec8-13012c596235
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PodSKAN HF Diagnostic X-ray System
• Version Model Number: 303-002665-0
• 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	08904269415105 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231761

FDA Product Code

• KPR: System, X-Ray, Stationary

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: 2024-01-01
• Device Publish Date: 2023-12-22

Devices Manufactured by SKANRAY TECHNOLOGIES LIMITED

• 08904269415105 - PodSKAN HF Diagnostic X-ray System: 2024-01-01PodSKAN is an advanced high frequency type X-Ray system designed for superior image quality with powerful 2.8KW generator and very low leakage radiation. The system houses two microprocessors, one for control/supervisory functions and another one man-machine/User interface. It can be easily plugged into 16A Wall socket with 120 VAC or 240 VAC, 50/60 Hz.. The technology incorporates feedback circuits to ensure highest accuracy & reproducibility of X-Ray output.
• 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
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• 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