FDA.report

510(k) K232088

Device
Altris IMS
Applicant
Altris, Inc.
510(k) number
K232088
Product code
NFJ
Decision
Substantially Equivalent (SESE)
Decision date
2023-07-31
Date received
2023-07-13
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
Yes

Related Records

Applicant Contact

Contact
Andrew Kuropyatnyk
Address
125 S. Clark St., 17th Floor Chicago IL US 60603 60603

FDA Registration Numbers

Source Documents

510(k) summary PDF

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