LEONI ORION System— 510(k) K160518
Substantially EquivalentLeoni Cia Cable System
FDA 510(k) clearance K160518 for LEONI ORION System, Substantially Equivalent on 2016-07-14. Applicant: Leoni Cia Cable System. Device class: 2.
Clearance details
- Applicant
- Leoni Cia Cable System
- Product code
- Code JAI
- Device class
- Class 2
- Regulation
- 21 CFR 892.5770
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Chartres, FR
Recent devices under product code JAI
view allRecalls naming K160518
K-number listed on FDA's recall record- Z-0398-2024 — 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
- Z-0399-2024 — 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: 1SOPT00009
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K160518.
Data sourced from openFDA. This site is unofficial and independent of the FDA.