FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCH— 510(k) K122938

Name: FDA 510(k) clearance K122938
Creator: U.S. Food and Drug Administration
Published: 2012-11-02

Substantially Equivalent

Carl Zeiss Meditec, AG

FDA 510(k) clearance K122938 for FORUM FORUM ARCHIVE FORUM ARCHIVE & VIEWER FORUM ASSIST MATCH, Substantially Equivalent on 2012-11-02. Applicant: Carl Zeiss Meditec, AG. Device class: 2.

Clearance details

Applicant: Carl Zeiss Meditec, AG
Product code: Code NFJ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2012-09-24
Decision date: 2012-11-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dublin, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NFJ

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K260694 — ZEISS CLINIC 3602026-07-17
K253893 — Harmony Referral System with Harmony OCT Viewer (Octave)2026-06-04
K234076 — iCare ALTIUS CW2024-08-22
K232828 — IMAGEnet6 Ophthalmic Data System2024-03-01
K232944 — CALLISTO eye2023-12-21

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K233421 — RESCAN 7002024-03-08
K232159 — QEVO System2023-09-21

Recalls naming K122938

K-number listed on FDA's recall record

Z-1049-2015 — FORUM Archive and Viewer, version 3.1, v 3.1.1, (DVD Format) and v 3.2, v 3.2.1.(DVD and USB Flash Drive Format). Catalog numbers: 000000-20107-750 (DVD with either FORUM v 3.1 or v 3.1.1) 000000-2058-601 (DVD with either FORUM v 3.2 or 3.2.1); 000000-2084-928 (USB drive with FORUM 3.2.1) Ophthalmic image management system.Class II·Terminated·Carl Zeiss Meditec AG·20150122

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K122938.

Data sourced from openFDA. This site is unofficial and independent of the FDA.