Collimator AL02 II El
Catalogue number 10092614, listed by Siemens Healthcare Limited, Canada, 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
1510(k) clearance
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 | Siemens Healthcare Limited, Canada |
|---|---|
| FDA product code | KPW |
| Device type | Device, Beam Limiting, X-Ray, Diagnostic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1610 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2016-10-23 |
| Record revised | 2021-11-18 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Handling environment temperature 10 to 40 °C; Handling environment atmospheric pressure 70 to 106 KiloPascal; Storage environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 10 to 95 % RH; Handling environment humidity 20 to 75 % RH; Storage environment temperature -40 to 70 °C |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 10092614 | 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 |
| 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 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K781984 | 1978-12-04 |
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.