Image Diagnostics, Inc

Idi,radiation Shield System,protego,adapted Fixed Ceiling Mount,metric Accessory RAILS,PHILIPS,23" - 28" Width Table Top,with Mobile BARRIER#A800-0532-PH01

Registry build 21.09.26
5manufacturers in China registered for this device type
21catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (2), Shanghai (2), Tianjin (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code IWX
Manufacturer City Province Registered as Device types
Tianjin Kanghuajianye Medical Materials Co., Ltd. Tianjin Tianjin Contract manufacturer 1
Guangzhou Four E’s Scientific Co., Ltd. Guangzhou Guangdong Contract manufacturer 61
Shanghai Hua En Industrial Co Ltd Shanghai Shanghai Contract manufacturer 52
Bgss Company Asia Limited Zhabei Shanghai Contract manufacturer 25
Medipack Medical Packaging MFG. Co. Dongguan Guangdong Contract manufacturer 5

Record

Regulatory record for Image Diagnostics, Inc
Listed by Image Diagnostics, Inc., United States
FDA product code IWX
Device type Barrier, Control Panel, X-Ray, Movable
Device class Class 1
Regulation 21 CFR 892.6500
Establishment Manufacturer
Premarket notification Exempt
Record published 2025-07-02
Record revised 2025-07-03 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries lot or batch number, manufacturing date, serial number
Distribution end date 2023-06-08

Catalogue Numbers

Catalogue numbers for Image Diagnostics, Inc
Catalogue number Size Status
Protego MRS System for GE Table Tops w/Metric Accessory Rails In distribution
Compass Frame Stand-Alone Unit In distribution
Protego MRS System for Large Table Tops w/Metric Accessory Rails In distribution
Compass Flex w/32″ 4K monitor In distribution
Protego MRS System for Toshiba Table Tops w/Metric Accessory Rails In distribution
Compass Flex w/dual 27″ HD monitors In distribution
Compass Flex w/no monitor In distribution
Protego MRS System for Small Table Tops w/Metric Accessory Rails In distribution
Protego MRS System for Large Table Tops w/Metric Accessory Rails In distribution
Protego AFCM System for Philips Tables & SKYTRON boom arm In distribution
Protego MRS System for Small Table Tops w/Metric Accessory Rails In distribution
Protego FCM System for Philips Tables In distribution
Compass Contour Suspended System with 1 Arm In distribution
Protego MRS System for Large Table Tops w/Metric Accessory Rails In distribution
Protego MRS System for Toshiba Table Tops w/Metric Accessory Rails In distribution
Compass Flex w/32″ HD monitor In distribution
Protego MRS System for Large Table Tops w/Metric Accessory Rails In distribution
Compass Flex w/dual 19″ HD monitors In distribution
Protego Mobile Barrier In distribution
Protego MRS System for GE Table Tops w/Metric Accessory Rails In distribution
Compass Contour Stand-Alone Unit Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Aadco Aadco Medical, Inc. 214
Hercules Aadco Medical, Inc. 126
WD Mavig Gmbh 63
MRI-Safe Aadco Medical, Inc. 46
ScatPad Cardio Medical Products, Inc. 18
Techno-Aide Techno-Aide, Inc. 15
Kenex Kenex (Electro-Medical) Ltd. 15
MasterPeace Texray AB 14
ErgoLite Aadco Medical, Inc. 8
PlastCare Proguard Health Inc. 5
Britedent Bright Supply Inc 4
Dental City ICP, Inc. 3

Showing 12 of 20. All products under Barrier, Control Panel, X-Ray, Movable

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