FDA.report

510(k) K234076

Device
iCare ALTIUS CW
Applicant
Centervue S.P.A.
510(k) number
K234076
Product code
NFJ
Decision
Substantially Equivalent (SESE)
Decision date
2024-08-22
Date received
2023-12-21
Regulation
892.2050
Classification name
System, Image Management, Ophthalmic
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Luca Scienza
Address
Via San Marco 9h Padova IT 35129 35129

FDA Registration Numbers

Source Documents

510(k) summary PDF

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