UD150B-40
7 catalogue numbers from 502-23370-11, listed by Shimadzu Corp., United States, under Generator, High-Voltage, X-Ray, Diagnostic. 6 manufacturers in China are registered for this product code.
6manufacturers in China registered for this device type
7catalogue numbers in this listing
4510(k) clearances naming this product code
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 | Shimadzu Corp., United States |
|---|---|
| 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 | 2016-12-27 |
| Record revised | 2025-05-28 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 502-23370-11 | In distribution | |
| 562-23370-11 | In distribution | |
| 562-23370-74 | In distribution | |
| 502-23370-50 | In distribution | |
| 502-23370-58 | In distribution | |
| 565-10274-79 | In distribution | |
| 502-23370-53 | 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 |
| XS-100 Generator | Philips Medical Systems DMC GmbH | 6 |
Showing 12 of 49. All products under Generator, High-Voltage, X-Ray, Diagnostic
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K952822 | 1995-07-12 |
| K942731 | 1994-10-13 |
| K934967 | 1993-12-13 |
| K933471 | 1993-11-24 |
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.