Sedecal
High frequency diagnostic x-ray generator
6manufacturers in China registered for this device type
88catalogue 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 | Sedecal., Sa., Spain |
|---|---|
| FDA product code | IZO |
| Device type | Generator, High-Voltage, X-Ray, Diagnostic |
| Device class | Class 1 |
| Regulation | 21 CFR 892.1700 |
| Premarket notification | Exempt |
| Record published | 2016-10-31 |
| Record revised | 2025-01-20 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -40 to 70 °C; Storage environment humidity 10 to 100 % RH; Storage environment atmospheric pressure 500 to 1060 millibar; Handling environment temperature 10 to 40 °C; Handling environment humidity 30 to 75 % RH; Handling environment atmospheric pressure 700 to 1060 millibar |
| Distribution end date | 2025-01-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SHF-1030-M | In distribution | |
| SHFR400 | In distribution | |
| SHF-415-C | In distribution | |
| SHF-410 | In distribution | |
| SHF-210 | In distribution | |
| SHF-215 | In distribution | |
| SHF-310PSU | In distribution | |
| SHFR200 | In distribution | |
| SHFR600 | In distribution | |
| SHF-1020 | In distribution | |
| SHF-0530-M | In distribution | |
| SHF-1610PSU | In distribution | |
| SHF-420 | In distribution | |
| SHFR100 | In distribution | |
| SHF-835 | In distribution | |
| SHF-225 | In distribution | |
| SHF-415 | In distribution | |
| SHF-215PSU | In distribution | |
| SHFR600 | In distribution | |
| SHFR800 | In distribution | |
| SHF-515PSU | In distribution | |
| SHF-415PSU | In distribution | |
| SHF-425 | In distribution | |
| SHF-0510-MPSTA | In distribution | |
| SHF-520 | In distribution | |
| SHF-220 | In distribution | |
| SHF-510-C | In distribution | |
| SHFR500 | In distribution | |
| SHF-315-C | In distribution | |
| SHF-610 | In distribution | |
| SHF-635 | In distribution | |
| SHFR800 | In distribution | |
| SHFR400 | In distribution | |
| SHF-1035 | In distribution | |
| SHF-620 | In distribution | |
| SHF-410-C | In distribution | |
| SHF-315PSU | In distribution | |
| SHFR200 | In distribution | |
| SHF-1615PSU | In distribution | |
| SHF-1630 | In distribution | |
| SHF-235 | In distribution | |
| SHF-1615-C | In distribution | |
| SHF-1620 | In distribution | |
| SHF-310-C | In distribution | |
| SHF-435 | In distribution | |
| SHF-320 | In distribution | |
| SHF-215-C | In distribution | |
| SHFR300 | In distribution | |
| SHF-1610 | In distribution | |
| SHF-625 | In distribution | |
| SHF-530 | In distribution | |
| SHF-1610-C | In distribution | |
| SHF-1625 | In distribution | |
| SHF-615 | In distribution | |
| SHF-1635 | In distribution | |
| SHF-210-C | In distribution | |
| SHF-430 | In distribution | |
| SHF-335 | In distribution | |
| SHFR500 | In distribution | |
| SHFR300 | In distribution | |
| SHF-630 | In distribution | |
| SHF-1025 | In distribution | |
| SHF-410PSU | In distribution | |
| SHF-535 | In distribution | |
| SHF-230 | In distribution | |
| SHF-310 | In distribution | |
| SHFR100 | In distribution | |
| SHF-1010 | In distribution | |
| SHF-525 | In distribution | |
| SHF-1010-MPSTA | In distribution | |
| SHF-515 | In distribution | |
| SHF-510 | In distribution | |
| SHF-1030 | In distribution | |
| SHF-510PSU | In distribution | |
| SHF-515-C | In distribution | |
| SHF-1015 | In distribution | |
| SHF-1010-M | In distribution | |
| SHF-325 | In distribution | |
| SHF-330 | In distribution | |
| SHF-0510-M | In distribution | |
| SHF-315 | In distribution | |
| SHF-210PSU | In distribution | |
| SHF-1615 | In distribution | |
| HERCULES-32 | Withdrawn | |
| HERCULES-50 | Withdrawn | |
| HERCULES-40 | Withdrawn | |
| HERCULES-65 | Withdrawn | |
| HERCULES-80 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Varex Imaging | Varex Imaging Corporation | 102 |
| 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 |
| iRay | iRay Imaging Technology (Haining) Limited | 25 |
| 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.