Altris IMS

FDA 510(k) K232088 · Altris, Inc.

Substantially Equivalent

510(k) numberK232088

Submission

Device name
Altris IMS
Applicant
Altris, Inc.
Chicago, IL, US
Received
July 13, 2023
Decision date
July 31, 2023
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

Official FDA 510(k) record

Device classification

Product code
NFJ – System, Image Management, Ophthalmic
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

Other 510(k)s with product code NFJ

510(k)DeviceApplicantDecision
K260694Zeiss Clinic 360NFJ · Traditional Carl Zeiss Meditec, AG07/17/2026SE
K253893Harmony Referral System with Harmony OCT Viewer (Octave)NFJ · Traditional Topcon Healthcare Solutions EMEA Oy06/04/2026SE
K234076iCare ALTIUS CWNFJ · Traditional Centervue S.P.A.08/22/2024SE
K232828IMAGEnet6 Ophthalmic Data SystemNFJ · Traditional Topcon Corporation03/01/2024SE
K232944CALLISTO eyeNFJ · Special Carl Zeiss Meditec, AG12/21/2023SE
K232555HarmonyNFJ · Special Topcon Healthcare Solutions11/20/2023SE
K231676CALLISTO eyeNFJ · Traditional Carl Zeiss Meditec, AG08/28/2023SE
K220929ExcelsiorNFJ · Traditional Merit Cro, Inc.10/31/2022SE
K213527ForumNFJ · Traditional Carl Zeiss Meditec, AG08/15/2022SE
K211715RetinAI DiscoveryNFJ · Traditional Retinai Medical AG04/28/2022SE

Questions and answers

When was Altris IMS cleared by the FDA?

Altris IMS (K232088) received a 510(k) decision of Substantially Equivalent on July 31, 2023, 18 days after the submission was received.

What is the product code of K232088?

The FDA product code is NFJ – System, Image Management, Ophthalmic, a Class II (moderate risk) device regulated under 21 CFR 892.2050.