X-Ray Beam Filter Kit
4X4 X-ray Beam Filter Kit
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 | Carestream Health, Inc., United States |
|---|---|
| FDA product code | KPW |
| Device type | Device, Beam Limiting, X-Ray, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1610 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K837334 |
| Record published | 2016-09-16 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number |
| Packaging | Case of 20 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| X-ray Beam Filter Kit | In distribution |
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 |
| Device, Beam Limiting, X-Ray, Diagnostic | Yoshida Denzai Kogyo Co., Ltd. | 1 |
| Collimator AL02 II eL | Siemens Healthcare Limited | 1 |
| Philips Medical Systems DMC | Villa Sistemi Medicali SPA | 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.