EFILM WORKSTATION— 510(k) K012211

Name: FDA 510(k) clearance K012211
Creator: U.S. Food and Drug Administration
Published: 2001-07-31

Substantially Equivalent

Efilm Medical, Inc.

FDA 510(k) clearance K012211 for EFILM WORKSTATION, Substantially Equivalent on 2001-07-31. Applicant: Efilm Medical, Inc.. Device class: 2.

Clearance details

Applicant: Efilm Medical, Inc.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 2001-07-16
Decision date: 2001-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Toronto, Ontario, CA

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLZ

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More clearances from Efilm Medical, Inc.

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K020995 — EFILM WORKSTATION WITH MODULES2002-04-12
K013631 — EFILM VIDEO2001-11-20

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K012211

K-number listed on FDA's recall record

Z-0068-2015 — eFilm Workstation 4.0 and 4.0.1. eFilm Workstation is one of the components of a PACS (Picture Archiving and Communications System). Product Usage: eFilm Workstation is a software application that is used for viewing medical images. eFilm Workstation receives digital images and data from various sources (including but not limited to CT,MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). Images are stored, communicated, processed and displayed on the local disc of a workstation and/or across computer networks at distributed locations. Tasks that users may perform when viewing images include, but are not limited to: adjustment of window width and level; image stacking; annotation and measurement of regions of interest; and inversion, rotation, and flips of images. In addition, eFilm Workstation can be integrated with an institution s existing HIS or RIS for a fully integrated electronic patient record.Class II·Terminated·Merge Healthcare, Inc.·20140828

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K012211.

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