Data / Medical devices / United States / Radlink, Inc.
Radlink, Inc.: FDA-registered device maker in El Segundo, CA, United States, 4 510(k) clearances
Radlink, Inc. is registered with the FDA (registration 3005560996) in El Segundo, CA, United States. It lists 1 device type. The FDA files 4 510(k) clearances under its listings, the newest dated September 8, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3005560996
- Address
- 2101 E El Segundo Blvd, Suite 104, El Segundo, CA, United States, 90245
- Owner or operator
- RADLINK, INC. (9048903)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- June 11, 2013
- Registered through
- 2026
- Brand names listed
- Galileo Positioning System (GPS), PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector, Radlink Bucky Cart, Radlink DR Pro, Radlink GPS, Radlink GPS Tablet, Radlink Galileo Positioning System, Radlink OR Pro and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Solid State X-Ray Imager (Flat Panel/Digital Imager) | MQB | 2 | Manufacturer, Repackager or relabeler | 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 |
|---|---|---|---|---|---|---|
| September 8, 2016 | K161966 | PerkinElmer XRpad2 4336 HWC-M Flat Panel Detector | MQB | Substantially Equivalent | Perkinelmer, Inc. | accessdata.fda.gov |
| December 17, 2014 | K142718 | Radlink GPS | MQB | Substantially Equivalent | Radlink, Inc. | accessdata.fda.gov |
| February 1, 2013 | K122865 | VIVIX-S WIRELESS | 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
Updated September 8, 2016. 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.