Varex Imaging
The device is intended to be used in medical diagnostic applications with restrictions to human diagnostics as an accessory of an X-ray system in a professional healthcare facility…
The device is intended to be used in medical diagnostic applications with restrictions to human diagnostics as an accessory of an X-ray system in a professional healthcare facility environment and is intended to be holding image receptor. The device is one out of the Harmony 3-series.
Who Else Makes It
Concentrated in Beijing (2), Shanghai (2), Guangdong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Siemens Shanghai, Medical Equipment Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Dongguan Wanjin Industrial Co., Ltd. | Dongguang | Guangdong | Remanufacturer | 41 |
| Jinyuan Medical Equipment(Tianjin)Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 27 |
| GE Hangwei Medical Systems Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| GE Healthcare (China) Co., Ltd. | Beijing | Beijing | Specification developer | 22 |
| Carestream Health, Inc., Global R&D Center | Shanghai | Shanghai | Specification developer | 8 |
Record
| Listed by | Varex Imaging Nederland B.V., Netherlands |
|---|---|
| FDA product code | IXY |
| Device type | Holder, Radiographic Cassette, Wall-Mounted |
| Device class | Class 1 |
| Regulation | 21 CFR 892.1880 |
| Establishment | Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2019-07-24 |
| Record revised | 2024-08-13 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2024-08-13 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 19408-02 | Withdrawn | |
| 19408-01 | Withdrawn | |
| 19408-10 | Withdrawn | |
| 19409-09 | Withdrawn | |
| 19408-09 | Withdrawn | |
| 19407-02 | Withdrawn | |
| 20947-00 | Withdrawn | |
| 19387-02 | Withdrawn | |
| 19409-01 | Withdrawn | |
| 19408-08 | Withdrawn | |
| 20949-00 | Withdrawn | |
| 19407-05 | Withdrawn | |
| 19407-06 | Withdrawn | |
| 19386-03 | Withdrawn | |
| 19388-04 | Withdrawn | |
| 19388-03 | Withdrawn | |
| 19409-08 | Withdrawn | |
| 19387-07 | Withdrawn | |
| 19407-08 | Withdrawn | |
| 19407-07 | Withdrawn | |
| 19409-10 | Withdrawn | |
| 19408-04 | Withdrawn | |
| 19408-06 | Withdrawn | |
| 19409-02 | Withdrawn | |
| 19386-01 | Withdrawn | |
| 19387-04 | Withdrawn | |
| 19408-05 | Withdrawn | |
| 19387-08 | Withdrawn | |
| 19407-03 | Withdrawn | |
| 19409-05 | Withdrawn | |
| 19387-05 | Withdrawn | |
| 19407-09 | Withdrawn | |
| 19410-01 | Withdrawn | |
| 19409-07 | Withdrawn | |
| 19387-03 | Withdrawn | |
| 19387-01 | Withdrawn | |
| 20948-00 | Withdrawn | |
| 19409-06 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BR-120 | Shimadzu Corp. | 21 |
| BR-120T | Shimadzu Corp. | 19 |
| BR-120M | Shimadzu Corp. | 9 |
| Summit | Summit Industries, LLC | 8 |
| Holder, Radiographic Cassette, Wall-Mounted | Ge Hualun Medical Systems Co., Ltd. | 8 |
| Del Medical, Inc. | DEL Medical, Inc. | 7 |
| Sedecal | Sedecal., Sa. | 6 |
| Kenex | Kenex (Electro-Medical) Ltd. | 5 |
| QW-420-T | Carestream Health, Inc. | 5 |
| Discovery RF180 | General Medical Merate SPA | 4 |
| Grid entity | Protec GmbH & Co. KG | 3 |
| Drgem | Drgem Corporation | 3 |
Showing 12 of 54. All products under Holder, Radiographic Cassette, Wall-Mounted
Recalls
2 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2014-03-15 | Class II | Radiation Control for Health and Safety Act | Claymount Assemblies BV is recalling the Harmony2 model of Harmony Bucky because 1) the devices are incorrectly labeled in that the label does not list the manufacturer address, the date of manufacture, or a statement of compliance with 21 | 12 devices | 2018-10-18 |
| 2014-03-15 | Class II | Radiation Control for Health and Safety Act | Harmony1 models of the Harmony Bucky is incorrectly labeled in that the label does not list the manufacturer address, the date of manufacture, or a statement of compliance with 21 CFR Subchapter J. | 125 units shipped to United States | 2018-10-18 |
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.