Mobiles
!M1
ONYX
Rafale / Rafale DR
NEW
!M1
Setting New Standards in Mobile X-Ray
Come back later to see a dedicated webpage of the product.
This product is manufactured by Solutions for tomorrow AB, and certified as a medical device class IIb in the European Union under the Medical Device Directive 93/42/EEC by PCBC n°1434, exclusively to perform general radiography x-ray examinations. Photos are not contractually binding. Read the operating instructions carefully.
NEW
ONYX
Ultra mobile & smart, accurate diagnosis anywhere
Come back later to see a dedicated webpage of the product.
ONYX is a Class IIb medical device manufactured by APELEM SAS and does not yet bear the CE marking. It will be certified in the European Union under the Medical Device Regulation 2017/745/EU by Eurofins Electric & Electronics Finland Oy (CE 0537), exclusively for the indication to perform radiographic X-ray examinations on pediatric and adult patients, on all patient’s treatment areas. Other non-medical uses ascribed to this device are not within the scope of CE certification. Read the operating instructions carefully. ONYX has not yet been approved or cleared by FDA. Photos are non-contractual. This project was financed by the French government as part of the recovery plan and the investment program for the future.
Rafale / Rafale DR
Compact, lightweight, and easy-to-operate mobile units
These products are certified as medical devices class IIb in the European Union under the Medical Device Directive 93/42/EEC by IMQ, exclusively for the indication(s) of radiodiagnosis. Photos are not contractually binding.
X-RAY MOBILE SYSTEM — !M1 — Class IIb — CE 1434
X-RAY MOBILE SYSTEM — ONYX — Class IIb — Certification under process
X-RAY MOBILE SYSTEM — RAFALE Range — Class IIb — CE 0051