# K013631: Efilm Video

- Pathway: 510(k) (Traditional)
- Applicant: Efilm Medical, Inc.
- Decided: Nov 20, 2001 after 15 days
- Product code: LMA (Digitizer, Image, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2030
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K000411 (2000). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K000411: Chili Video, Chili Videopro, Steinbeis-Transferzentrum Medizinische Informatik (2000) Summary page 1.

## Indications for use
eFilm Video™ is a software application that captures video streams from analogue medical image acquisition devices with video outputs and converts these streams to DICOM compliant cine loops. These images can be sent to DICOM compliant devices for display and processing. Users may also input patient demographic information that is related to the captured images. Typical users of eFilm Video™ are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others.

Source page: https://510kreport.com/device/K013631
Methodology: https://510kreport.com/methodology