Data / Medical devices / Table, Radiographic, Non-Tilting, Powered
Table, Radiographic, Non-Tilting, Powered (IZZ): 22 FDA-registered makers in 11 countries
22 establishments in 11 countries are registered with the FDA to make Table, Radiographic, Non-Tilting, Powered (product code IZZ, Class 2, 21 CFR 892.1980). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 29 510(k) clearances under this code, the latest on May 14, 1997, and lists 7 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- IZZ
- Device class
- 2
- Regulation
- 892.1980
- Medical specialty
- Radiology
Makers by country
| Country | Makers |
|---|---|
| United States | 6 |
| South Korea | 4 |
| China | 3 |
| Israel | 2 |
| Sweden | 1 |
| Japan | 1 |
| Mexico | 1 |
| Netherlands | 1 |
| Germany | 1 |
| Spain | 1 |
| India | 1 |
Makers of Table, Radiographic, Non-Tilting, Powered
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Arcoma AB | VAXJO Kronoberg, Sweden | Complaint file establishment, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Accogent Pausch | Eatontown, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carestream Health, Inc., Global R&D Center | Shanghai, China | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CBH Inc | Jeonju-si Jeonbuk, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Carestream Health, Inc | Rochester, NY, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Del Medical, Inc. | Bloomingdale, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DK Medical Systems Co., Ltd. | Pyeongtaek-si Gyeonggi, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Drgem Corporation | Gwangmyeong-si Gyeongbuk, South Korea | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| DRGEM Corporation (Gimcheon Factory) | Gimcheon-si Gyeongbuk, South Korea | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Hangwei Medical Systems Co., Ltd. | Beijing, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Healthcare (China) Co., Ltd. | Beijing, China | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GE Healthcare Japan Corporation | HINO-SHI Tokyo, Japan | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Medical Systems Israel, Functional Imaging | TIRAT HACARMEL Haifa, Israel | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Medical Systems Israel, Functional Imaging | Haifa, Israel | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ge Medical Systems Monterrey Mexico, S.A. De C.V. | APODACA Nuevo Leon, Mexico | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Image Diagnostics, Inc. | Fitchburg, MA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Oakworks, Inc. | New Freedom, PA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips Medical Systems Nederland B.V. | BEST Noord-Brabant, Netherlands | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Philips Medical Systems DMC GmbH | Hamburg, Germany | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sedecal S.A. | ALGETE Madrid(Province), Spain | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Summit Industries, LLC | Niles, IL, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Wipro Ge Medical Device Manufacturing Private Limited | Bangalore Karnataka, India | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated May 14, 1997. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.