Data / Medical devices / France / BizLink Robotic Solutions France
BizLink Robotic Solutions France: FDA-registered device maker in Chartres Eure-et-Loir, France, 1 510(k) clearance
BizLink Robotic Solutions France is registered with the FDA (registration 3012834372) in Chartres Eure-et-Loir, France. It lists 1 device type. The FDA files 1 510(k) clearance under its listings, the newest dated July 14, 2016. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3012834372
- Address
- 5 avenue Victor Hugo, Chartres Eure-et-Loir, France, 28000
- Owner or operator
- BizLink Robotic Solutions France (10055323)
- Roles
- Manufacturer
- First device listed
- July 7, 2017
- Registered through
- 2026
- Brand names listed
- Orion System
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Couch, Radiation Therapy, Powered | JAI | 2 | Manufacturer | 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 |
|---|---|---|---|---|---|---|
| July 14, 2016 | K160518 | LEONI ORION System | JAI | Substantially Equivalent | Leoni Cia Cable System | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 6, 2023 | 93315 | Class II | Ongoing | ORION System with software OSS v6.0 and OSS v7.0- An electro-mechanical robotic arm for patient positioning in Radiation Therapy, Radiology, or Radiology image-guided treatment environment. Part Number: 1SOPT00003 | Users of the patient positioning system ORION System can be faced with a sudden short-term acceleration or with an unintended short-distance movement when the movements are again allowed after an unforeseen interruption signal of motion may result in a collision of the patient with another stationary component of the treatment room. | accessdata.fda.gov |
Compare with other makers
Updated November 21, 2023. 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.