FDA clears SPINEsim v1.0 from Mdsim S.A. via 510(k)

FDA 510(k) clearance has been granted to Mdsim S.A. for SPINEsim v1.0 (product code LLZ), a radiology device, according to the agency's radiology device database.

• Cleared through the U.S. FDA 510(k) premarket notification pathway.
• Assigned product code LLZ and reviewed under the Radiology committee.
• Applicant: Mdsim S.A.

Automated summary

RadPigeon summaries are original and for information only. They are not clinical advice.