Data / Medical devices / United States / Medlink Imaging, LLC.
Medlink Imaging, LLC.: FDA-registered device maker in Pine Brook, NJ, United States, 17 510(k) clearances
Medlink Imaging, LLC. is registered with the FDA (registration 2433615) in Pine Brook, NJ, United States. It lists 6 device types. The FDA files 17 510(k) clearances under its listings, the newest dated May 6, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2433615
- Address
- 1 Chapin RD Ste 3, Pine Brook, NJ, United States, 07058
- Owner or operator
- MEDLINK IMAGING (2433615)
- Roles
- Complaint file establishment
- First device listed
- July 6, 1992
- Registered through
- 2026
- Brand names listed
- !M1, Medlink FC RAD ROOM, Medlink FDR, Medlink FDR-PLUS, Medlink SDR, Medlink SDR-PLUS, Medlink CDR, Medlink FM PREMIUM RAD ROOM, Medlink FM STANDARD RAD ROOM, Medlink JADE Mobile Solution, Medlink JADE Portable X-Ray System, Medlink M1 Mobile X-Ray System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Film, Radiographic | IWZ | 1 | Complaint file establishment | accessdata.fda.gov |
| Full Field Digital, System, X-Ray, Mammographic | MUE | 2 | Complaint file establishment | accessdata.fda.gov |
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Complaint file establishment | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment | accessdata.fda.gov |
| System, X-Ray, Mobile | IZL | 2 | Complaint file establishment | accessdata.fda.gov |
| System, X-Ray, Stationary | KPR | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 6, 2025 | K241980 | !M1 | IZL | Substantially Equivalent | Solutions For Tomorrow AB | accessdata.fda.gov |
| January 16, 2025 | K241113 | VIVIX-M | MUE | Substantially Equivalent | Vieworks Co., Ltd. | accessdata.fda.gov |
| November 15, 2024 | K241125 | VIVIX-S 1751S | MQB | Substantially Equivalent | Vieworks Co., Ltd. | accessdata.fda.gov |
| September 13, 2022 | K220239 | Solid State X-ray Imager(Model: FXRD-4386WB) | MQB | Substantially Equivalent | Vieworks Co., Ltd. | accessdata.fda.gov |
| July 20, 2022 | K221512 | Vivix-S FW (Model: FXRD-2530FAW, FXRD-3643FAW, FXRD-4343FAW) | MQB | Substantially Equivalent | Vieworks Co., Ltd. | accessdata.fda.gov |
| May 21, 2021 | K211423 | Rover | IZL | Substantially Equivalent | Micro-X Limited | accessdata.fda.gov |
| March 18, 2020 | K200418 | VIVIX-S VW | MQB | Substantially Equivalent | Vieworks Co., Ltd. | accessdata.fda.gov |
| January 2, 2020 | K193360 | Acuity SDR Standard, Acuity SDR Plus, Acuity FDR Standard | KPR | Substantially Equivalent | Radmedix, LLC | accessdata.fda.gov |
| September 26, 2019 | K192364 | GXR-Series Diagnostic X-Ray System | KPR | Substantially Equivalent | DRGEM Corporation | accessdata.fda.gov |
| February 5, 2019 | K183388 | JADE Mobile X-Ray | IZL | Substantially Equivalent | DRGEM Corporation | accessdata.fda.gov |
| July 17, 2017 | K170607 | !M1 | IZL | Substantially Equivalent | Solutions For Tomorrow AB | accessdata.fda.gov |
| February 8, 2017 | K163703 | VIVIX-S 1417N | MQB | Substantially Equivalent | Vieworks Co., Ltd. | accessdata.fda.gov |
| August 5, 2016 | K161113 | QXLink | LLZ | Substantially Equivalent | Vieworks Co., Ltd. | accessdata.fda.gov |
| February 26, 2016 | K152894 | VIVIX-S 1717N | MQB | Substantially Equivalent | Vieworks Co., Ltd. | accessdata.fda.gov |
| February 26, 2016 | K152855 | VIVIX-S 1012N | MQB | Substantially Equivalent | Vieworks Co., Ltd. | accessdata.fda.gov |
| January 11, 2013 | K122866 | VIVIX-S WITH VXVUE | MQB | Substantially Equivalent | Vieworks Co., Ltd. | accessdata.fda.gov |
| May 4, 2012 | K120020 | VIVIX-S | MQB | Substantially Equivalent | Vieworks Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Solid State X-Ray Imager (Flat Panel/Digital Imager)
- All makers of System, X-Ray, Mobile
- All makers of Full Field Digital, System, X-Ray, Mammographic
- All makers of Film, Radiographic
- All makers of System, X-Ray, Stationary
- All makers of System, Image Processing, Radiological
Updated May 6, 2025. 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.