Device, Beam Limiting, X-Ray, Diagnostic
Catalogue number YS-3GA, listed by Yoshida Denzai Kogyo Co., Ltd., under Device, Beam Limiting, X-Ray, Diagnostic. 2 manufacturers in China are registered for this product code.
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Shanghai (1), Zhejiang (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Fairy Medical Electrics(Jiaxing)Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 3 |
Record
| Listed by | Yoshida Denzai Kogyo Co., Ltd. |
|---|---|
| FDA product code | KPW |
| Device type | Device, Beam Limiting, X-Ray, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1610 |
| Premarket notification | Exempt |
| Record published | 2017-09-13 |
| Record revised | 2024-06-21 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -40 to 120 °F; Storage environment humidity 5 to 95 % RH; Handling environment temperature 60 to 100 °F; Handling environment humidity 5 to 85 % RH; Handling environment atmospheric pressure 69 to 106 KiloPascal |
| Sizes | Weight 8.5 kg; depth 227 mm; width 316 mm; height 277 mm |
| Distribution end date | 2023-11-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| YS-3GA | Weight 8.5 kg | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ralco srl | Ralco SRL | 10 |
| Villa Sistemi Medicali | Villa Sistemi Medicali SPA | 2 |
| X-ray beam limiting device | Canon Inc. | 1 |
| Collimator AL02 II eL | Siemens Healthcare Limited | 1 |
| Philips Medical Systems DMC | Villa Sistemi Medicali SPA | 1 |
| X-ray Beam Filter Kit | Carestream Health, Inc. | 1 |
| Collimator ML01 II | Siemens Healthcare Limited | 1 |
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.