510(k) · Cleared
ClearedEfilm Video
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Efilm Medical, Inc. · LMA Digitizer, Image, Radiological
Cleared on Nov 20, 2001 as substantially equivalent to K000411 (Steinbeis-Transferzentrum Medizinische Informatik, 2000) after a 15-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Nov 20, 2001
- Review
- 15 days
- Class
- Class II
- Product code
- LMA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000411 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK000411 Chili Video, Chili VideoproSteinbeis-Transferzentrum Medizinische Informatik · 2000
- This deviceK013631 Efilm VideoEfilm Medical, Inc. · 2001
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000411 | Chili Video, Chili Videopro | Steinbeis-Transferzentrum Medizinische Informatik | 2000 | — |
| 0 (this device) | K013631 | Efilm Video | Efilm Medical, Inc. | 2001 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LMA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K000411 | Chili Video, Chili VideoproSummary page 1…age Digitizer = Predicate Device: CHILI Video/Pro Video Predicate Device Manufacturer: STEINBEIS-TRANSFERZENTRUM MEDIZINISCHE INFORMATIK Predicate Device 510(k) Number: K000411 Date Received: 02/08/2000 Decision Date: 04/14/2000 Decision: Substantially Equivalent Panel Code Device Reviewed by: Radiology… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 3 other devices also cite its predicate K000411.
How does its category compare?
All LMA devicesLMA Digitizer, Image, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LMA
3in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · LMA
80in 2013
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LMA
1in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LMA
1in 2013
MAUDE reports naming product code LMA, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 3 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 2 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 3 | 80 | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 1 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K013631 · printed Nov 4, 2026
Cite this page
510(k) Report. “K013631: Efilm Video.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K013631
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026