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

Mobile basic diagnostic x-ray system, digital
Primary Device ID08904269403522
NIH Device Record Key714d6ac5-108b-4754-b043-c00c45dfd317
Commercial Distribution StatusIn Commercial Distribution
Brand NameSKANMOBILE
Version Model Number303-000018-3
Company DUNS863358955
Company NameSKANRAY TECHNOLOGIES LIMITED
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108904269403522 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IZLSystem, X-Ray, Mobile

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2022-04-29
Device Publish Date2022-04-21

Devices Manufactured by SKANRAY TECHNOLOGIES LIMITED

08904269415105 - PodSKAN HF Diagnostic X-ray System2024-01-01 PodSKAN is an advanced high frequency type X-Ray system designed for superior image quality with powerful 2.8KW generator and ve
08904269409531 - SKANRAD 4002022-05-19 Skanrad 400 is an advanced high frequency type X-ray system designed for superior image quality for radiographic use with powerf
08904269403522 - SKANMOBILE2022-04-29Skanmobile 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 - SKANMOBILE2022-04-29 Skanmobile is a high frequency Mobile X-Ray System for diagnostic radiography. The system houses two microprocessors, one for co
08904269403683 - SKANMOBILE DR2022-04-29 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 system2022-01-19 SKAN-C, is a mobile X-Ray C-Arm fluoroscopic device to assist in guiding medical intervention surgical procedures. The device ca

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