Generator, High-Voltage, X-Ray, Diagnostic
Self-Compression Solution
6manufacturers in China registered for this device type
1catalogue number
4510(k) clearances naming this product code
1recall
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 | GE Medical Systems, LLC, United States |
|---|---|
| FDA product code | IZO |
| Device type | Generator, High-Voltage, X-Ray, Diagnostic |
| Device class | Class 1 |
| Regulation | 21 CFR 892.1700 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K162268 |
| Record published | 2017-09-13 |
| Record revised | 2025-11-07 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Handling environment temperature 15 to 40 °C; Storage environment atmospheric pressure 50 to 106 KiloPascal; Handling environment humidity 5 to 95 % RH; Storage environment temperature -40 to 70 °C; Storage environment humidity 5 to 95 % RH; Handling environment atmospheric pressure 50 to 106 KiloPascal |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5727669 | 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 |
| 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 |
Showing 12 of 49. All products under Generator, High-Voltage, X-Ray, Diagnostic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K954666 | 1995-11-24 |
| K943652 | 1994-08-22 |
| K931049 | 1993-05-19 |
| K892943 | 1989-05-22 |
Recalls Naming This Product
3 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| GE Medical Systems, LLC | 510(k) number | 2025-10-24 | Class II | Radiation Control for Health and Safety Act | Some Senographe Pristina systems either have a missing or an incorrect X-Ray Warning label, which is a nonconformance to FDA Regulation 21 CFR 1020.30(j). | 1,818 (1,580 US; 238 OUS) | |
| GE Medical Systems SCS | 510(k) number | 2023-12-26 | Class II | Radiation Control for Health and Safety Act | X-ray exposure termination audible signal on Senographe Pristina with Efficiency Suite 2 intermittently not emitted per 21CFR 1020.31(j) requirements. | 180 units (60 US; 120 OUS) | |
| GE Medical Systems, LLC | 510(k) number | 2019-05-16 | Class II | Equipment maintenance | Potential slippage of the biopsy positioner when the gantry is rotated during a biopsy procedure. | 82 | 2020-12-16 |
Recalls
The FDA has not published a severity grade for these. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2007-03-09 | Not classified | Component change control | GE Healthcare has recently become aware of a potential risk of monitor dropping associated with the monitor suspension of the Advantx system that may impact patient safety. It has been reported that suspensions manufactured after March 8, | 21 | 2012-08-24 |
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.