# K020995: Efilm Workstation with Modules

- Pathway: 510(k) (Traditional)
- Applicant: Efilm Medical, Inc.
- Decided: Apr 12, 2002 after 15 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K896095 (1990). 5 ancestors in all.
321 later devices descend from it; 15 cite it directly.
0 of 327 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012211: Efilm Workstation, Efilm Medical, Inc. (2001) Summary page 1.

## Most influential descendants
- 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
- K070618: Dicompacs, Model 5 (2007), 78 descendants of its own
- K063539: Nordic Image Control and Evaluation (Nice) Software, Version 2.1 (2007), 75 descendants of its own

## Recalls of this device
- Oct 20, 2016 · Class II · Z-0707-2017: A product issues happens for RF projection images. If user measures on RF image, .cal (Calibration) is not displayed and measurement is not correct. The .cal label is not displayed on the projection i
- 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 with Modules is a software application that is used for viewing medical images. eFilm Workstation with Modules 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). eFilm Workstation with Modules can be used to communicate, process and display medical images. Users have access to various image processing and measurement tools to assist them in viewing images. In addition, users can overlay templates on medical images to aid in preoperative planning. eFilm Workstation with Modules can be integrated with an institution’s existing HIS or RIS for a fully integrated electronic patient record. Typical users of eFilm Workstation with Modules are trained medical professionals, including but not limited to radiologists, technologists and clinicians.

Source page: https://510kreport.com/device/K020995
Methodology: https://510kreport.com/methodology