Image Diagnostics, Inc
Idi,radiation Shield System,scatter Guard,table Mount,iso-Drive Tables With Facial CUTOUT,#A610-407
78manufacturers in China registered for this device type
11catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (19), Jiangsu (13), Guangdong (10). 10 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Zhongshan Chukuang Textile Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 26 |
| Jiangsu Hanheng Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 20 |
| Honghu Danielle Sanitary Material Co., Ltd. | Honghu | Hubei | Contract manufacturer | 12 |
| Primed Liyang Medical Products Manufacturing Co., Ltd. | Liyang | Jiangsu | Contract manufacturer | 11 |
| Taijia Medical Electronics (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
| Gushi priMED Medical Products Manufacturing Co., Ltd. | Gushi County | Henan | Contract manufacturer | 9 |
| Wenzhou Weilan Optical Co., Ltd. | Wenzhou | Zhejiang | Contract manufacturer | 8 |
| priMED Jiujiang Medical Products Manufacturing Co., Ltd. | Jiujiang | Jiangxi | Contract manufacturer | 7 |
| Skytech Electronics (HK) Limited | Tsim Sha Tsui | Hong Kong | Contract manufacturer | 5 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu NEW Pentastar Medical Products Co., Ltd. | Changzhou | Jiangsu | Exporter | 146 |
Showing 12 of 78. All 78 manufacturers in China registered for Shield, Protective, Personnel
Record
| Listed by | Image Diagnostics, Inc., United States |
|---|---|
| FDA product code | KPY |
| Device type | Shield, Protective, Personnel |
| Device class | Class 1 |
| Regulation | 21 CFR 892.6500 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-10-23 |
| Record revised | 2024-12-31 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Distribution end date | 2024-12-31 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| RADIAL ARM BOARD RADIATION SHIELD PAD | 15 | In distribution | |
| SCATTER GUARD RADIATION SHIELD FOR 28IN WIDE TABLE | In distribution | ||
| FEMORAL SHIELD RADIATION SHIELD PAD | 15 | In distribution | |
| SCATTER GUARD RADIATION SHIELD FOR 24IN WIDE TABLE | In distribution | ||
| FIXED RADIATION SHIELD FOR TABLE TOP MOUNT | In distribution | ||
| ARTICULATING RADIATION SHIELD FOR U.S. ACCY RAILS | In distribution | ||
| SCATTER GUARD RADIATION SHIELD FOR 22IN WIDE TABLE | In distribution | ||
| ARTICULATING RADIATION SHIELD FOR METRIC ACCY RAILS | In distribution | ||
| SCATTER GUARD RADIATION SHIELD FOR ISO-DRIVE FACIAL TOP TABLE | In distribution | ||
| RADIAL ARM BOARD RADIATION SHIELD PAD | Withdrawn | ||
| FEMORAL SHIELD RADIATION SHIELD PAD | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Kenex | Kenex (Electro-Medical) Ltd. | 163 |
| Bloxr | Bloxr Solutions LLC | 125 |
| Aadco | Aadco Medical, Inc. | 104 |
| UT | Mavig Gmbh | 87 |
| CAP | Burlington Medical, LLC | 66 |
| Radpad | Worldwide Innovations & Technologies, Inc. | 59 |
| AngioSystems SorbX | Angiosystems, Inc. | 52 |
| Sleeve | Burlington Medical, LLC | 51 |
| Lead Lined | Biodex Medical Systems, Inc. | 40 |
| Molded Products, Inc. | Molded Products Inc. | 34 |
| MasterPeace | Texray AB | 30 |
| Halyard Scatter Radiation Shields | Angiosystems, Inc. | 30 |
Showing 12 of 134. All products under Shield, Protective, Personnel
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.