Skanmobile

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…

Registry build 21.09.26

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.

5manufacturers in China registered for this device type
1catalogue number
1510(k) clearance

Who Else Makes It

Concentrated in Beijing (2), Shanghai (1), Guangdong (1).

Chinese manufacturers registered for FDA product code IZL
Manufacturer City Province Registered as Device types
GE Hangwei Medical Systems Co., Ltd. Beijing Beijing Specification developer 22
GE Healthcare (China) Co., Ltd. Beijing Beijing Specification developer 22
Shanghai United Imaging Healthcare Co., Ltd. Shanghai Shanghai Manufacturer 12
Shantou Institute OF Ultrasonic Instruments Co., Ltd. Shantou Guangdong Contract manufacturer 8
Suzhou Powersite Electric Co., Ltd. Suzhou Jiangsu Manufacturer 2

Record

Regulatory record for Skanmobile
Listed by Skanray Technologies Limited, India
FDA product code IZL
Device type System, X-Ray, Mobile
Device class Class 2
Regulation 21 CFR 892.1720
Establishment Contract manufacturer, Complaint-file establishment, Manufacturer
510(k) K212940
Record published 2022-04-21

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Prescription Prescription only
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Skanmobile
Catalogue number Size Status
303-000018-3 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Siui Shantou Institute OF Ultrasonic Instruments Co., Ltd. 27
AcuityPDR RadmediX, LLC 24
Sedecal Sedecal., Sa. 20
Drgem Drgem Corporation 10
DRX-Revolution Mobile X-ray System Carestream Health, Inc. 7
MinXray Minxray, Inc. 6
System, X-Ray, Mobile Ecotron Co., Ltd. 6
MobileDaRt Evolution Shimadzu Corp. 5
Nomad MD™ handheld X-ray system Aribex, Inc. 5
Portable X-ray Unit Ajex Meditech., Ltd. 5
Diagnostic X-ray Unit Poskom Co., Ltd. 4
FDR Aqro Fujifilm Corporation 4

Showing 12 of 75. All products under System, X-Ray, Mobile

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K212940 2022-03-04

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer