Iray
Cetus 32F01 High-Voltage Generator
6manufacturers in China registered for this device type
25catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Anhui (1), Shanghai (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Siemens X-RAY Vacuum Technology Ltd. | Wuxi | Jiangsu | Contract manufacturer | 2 |
| Hefei MT Medical Co., Ltd. | Hefei | Anhui | Manufacturer | 23 |
| Carestream Health, Inc., Global R&D Center | Shanghai | Shanghai | Specification developer | 8 |
| iRay Imaging Technology (Haining) Limited | Haining | Zhejiang | Contract manufacturer | 6 |
| Suzhou Powersite Electric Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 2 |
| Spellman High Voltage Electronics(Suzhou Industrial Park)Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 2 |
Record
| Listed by | iRay Imaging Technology (Haining) Limited, China |
|---|---|
| FDA product code | IZO |
| Device type | Generator, High-Voltage, X-Ray, Diagnostic |
| Device class | Class 1 |
| Regulation | 21 CFR 892.1700 |
| Establishment | Contract manufacturer, Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-10-31 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Cetus 32F01 | In distribution | |
| Cetus 65F01 | In distribution | |
| Cetus 71R01 | In distribution | |
| Cetus 50F02 | In distribution | |
| Cetus 40F02 | In distribution | |
| Cetus 32R02 | In distribution | |
| Cetus 32F02 | In distribution | |
| Cetus 40R01 | In distribution | |
| Cetus 32R09 | In distribution | |
| Cetus 50R09 | In distribution | |
| Cetus 40F01 | In distribution | |
| Cetus 71F01 | In distribution | |
| Cetus 32R03 | In distribution | |
| Cetus 40F03 | In distribution | |
| Cetus 40R03 | In distribution | |
| Cetus 50R02 | In distribution | |
| Cetus 40R02 | In distribution | |
| Cetus 65R01 | In distribution | |
| Cetus 80R01 | In distribution | |
| Cetus 32F03 | In distribution | |
| Cetus 50F01 | In distribution | |
| Cetus 80F01 | In distribution | |
| Cetus 40R09 | In distribution | |
| Cetus 50R01 | In distribution | |
| Cetus 32R01 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Varex Imaging | Varex Imaging Corporation | 102 |
| Sedecal | Sedecal., Sa. | 88 |
| Varex Imaging | Varex Imaging Nederland B.V. | 61 |
| Editor HFe | Spellman High Voltage Electronics Corp. | 53 |
| Drgem | Drgem Corporation | 48 |
| S Spellman High Voltage Electronics Corporation | Spellman High Voltage Electronics(Suzhou Industrial Park)Co., Ltd. | 36 |
| Delta | Delta Electronics, Inc. Chungli 5 Plant | 22 |
| CMP 200 DR | Communications & Power Industries Canada, Inc. | 17 |
| Indico IQ | Communications & Power Industries Canada, Inc. | 12 |
| Epsilon High Voltage Generator | EMD Technologies Incorporated | 11 |
| UD150B-40 | Shimadzu Corp. | 7 |
| XS-100 Generator | Philips Medical Systems DMC GmbH | 6 |
Showing 12 of 49. All products under Generator, High-Voltage, X-Ray, Diagnostic
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.