510(k) · Cleared
ClearedLifejet Video Link
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ferrania S.P.A. · LMA Digitizer, Image, Radiological
Cleared on Oct 30, 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
- Oct 30, 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 deviceK013395 Lifejet Video LinkFerrania S.P.A. · 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) | K013395 | Lifejet Video Link | Ferrania S.P.A. | 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…image digitizer Trade name: LifeJet™ Video Link Classification Name: Medical image digitizer (per 21 CFR 892.2030) - 10.5 Predicate device: CHILI® Video (510(k) number: K000411), Steinbeis-Transferzentrum Medizinische Informatik, Im Neuenheimer Feld 517, D-69120 Heidelberg, Germany. 10.6 Description of d… | 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?
The LifeJet™ Video Link is a video image digitizer for the acquisition and conversion into digital format of medical images codified as analogue video signal.
The LifeJet™ Video Link has been developed to be used together with LifeJet™ Printers to produce referral prints of images coming out from ultrasound systems or other medical equipment through the video signal output.
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/K013395 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013395: Lifejet Video Link.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013395
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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