# K012211: Efilm Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Efilm Medical, Inc.
- Decided: Jul 31, 2001 after 15 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K896095 (1990). 4 ancestors in all.
333 later devices descend from it; 8 cite it directly.
0 of 338 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982862: Radworks Medical Imaging Software with Quality Control Module, Applicare Medical Imaging, B.V. (1998) Summary page 1.

## Most influential descendants
- K020995: Efilm Workstation with Modules (2002), 321 descendants of its own
- K032401: Orthoview (2003), 133 descendants of its own
- K042816: Traumacad 1.2 (2004), 129 descendants of its own
- K073714: Traumacad Version 2.0 (2008), 117 descendants of its own
- K052411: Hipax Medical Imaging Software (2005), 80 descendants of its own

## Recalls of this device
- Aug 28, 2014 · Class II · Z-0068-2015: There is an issue related to eFilm Workstation versions 4.0 and 4.0.1 when having multiple studies open and utilizing the thumbnail panel to select multiple series from multiple studies may lead to th

## Indications for use
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. Typical users of eFilm™ Workstation are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others.

Source page: https://510kreport.com/device/K012211
Methodology: https://510kreport.com/methodology