Ralco Srl
9 catalogue numbers from R 225 ACS DHHS, listed by Ralco SRL, under Collimator, Automatic, Radiographic. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
9catalogue 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 | Ralco SRL |
|---|---|
| FDA product code | IZW |
| Device type | Collimator, Automatic, Radiographic |
| Device class | Class 2 |
| Regulation | 21 CFR 892.1610 |
| Premarket notification | Exempt |
| Record published | 2016-08-04 |
| Record revised | 2018-03-29 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| R 225 ACS DHHS | In distribution | |
| P 313/A DHHS | In distribution | |
| R 302/144/A DHHS | In distribution | |
| R 302 ACS/A DHHS | In distribution | |
| R 915 S DHHS | In distribution | |
| R 605 DASM DHHS | In distribution | |
| S 605 DASM DHHS | In distribution | |
| R 302 DACS/A DHHS | In distribution | |
| P 225 ACS DHHS | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Claymount | Varex Imaging Nederland B.V. | 30 |
| Varex Imaging | Varex Imaging Nederland B.V. | 17 |
| Linear IV | Carestream Health, Inc. | 2 |
| 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.