Linear IV
R40-CS-P LIN IV Collimator W/65 FT Cable
5manufacturers in China registered for this device type
2catalogue numbers in this listing
Who Else Makes It
Concentrated in Beijing (2), Zhejiang (2), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Suzhou Shangchuang Technology Service Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 23 |
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| iRay Imaging Technology (Haining) Limited | Haining | Zhejiang | Contract manufacturer | 6 |
| Fairy Medical Electrics(Jiaxing)Co., Ltd. | Jiaxing | Zhejiang | Manufacturer | 3 |
Record
| Listed by | Carestream Health, Inc., United States |
|---|---|
| FDA product code | IZW |
| Device type | Collimator, Automatic, Radiographic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1610 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| 510(k) | K810598 |
| Record published | 2016-09-16 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | serial number |
| Distribution end date | 2016-10-18 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LINEAR IV | In distribution | |
| LINEAR IV | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Claymount | Varex Imaging Nederland B.V. | 30 |
| Varex Imaging | Varex Imaging Nederland B.V. | 17 |
| Ralco srl | Ralco SRL | 9 |
| R-300 | Shimadzu Corp. | 2 |
| iRay | iRay Imaging Technology (Haining) Limited | 1 |
| Vareximaging | Varex Imaging Nederland B.V. | 1 |
| Collimator Cradle 512 asm | Philips Digital Mammography Sweden AB | 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.