510(k) Report

510(k) · Cleared

Cleared

Dicom Video

K132183510(k) TraditionalCleared Oct 3, 201380-day reviewClass II21 CFR 892.2030

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bar Code Computer, Ltd. · LMA Digitizer, Image, Radiological

Cleared on Oct 3, 2013 as substantially equivalent to K000411 (Steinbeis-Transferzentrum Medizinische Informatik, 2000) after an 80-day review. Its family tree reaches back 1 generation to 2000.

Decided
Oct 3, 2013
Review
80 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.

K000411 · Chili Video, Chili Videopro · Steinbeis-Transferzentrum Medizinische Informatik · 20002000200520102015
K000411 · Chili Video, Chili Videopro · Steinbeis-Transferzentrum Medizinische Informatik · 20000
  1. Root · 1 generation backK000411 Chili Video, Chili VideoproSteinbeis-Transferzentrum Medizinische Informatik · 2000
  2. This deviceK132183 Dicom VideoBar Code Computer, Ltd. · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K000411Chili Video, Chili VideoproSteinbeis-Transferzentrum Medizinische Informatik2000—
0 (this device)K132183Dicom VideoBar Code Computer, Ltd.2013—
FIG. 1 — Lineage of K132183, 2000–2013Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K000411Chili Video, Chili VideoproSteinbeis-Transferzentrum Medizinische Informatik2000—

Also cleared against K000411: 3 other devices →

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 devices

LMA Digitizer, Image, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.

FDA decisions per year · LMA

3in 2013

2009: 12010: 22013: 3
2007high 3 (2013) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LMA

80in 2013

2013: 80 days median
2007high 80 (2013)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · LMA

1in 2019

2019: 1
2007high 1 (2019) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · LMA

1in 2013

2008: 32012: 12013: 1
2007high 3 (2008) · low 0 (2007)2025

MAUDE reports naming product code LMA, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—03
20091—00
20102—00
20110—00
20120—01
201338001
20140—00
20150—00
20160—00
20170—00
20180—00
20190—10
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The DICOM Video software package is intended for use by authorized personnel to acquire

individual or sequences of images and to allow the user to input patient demographics related to

the image. The device transforms imaging studies to DICOM format before they are made

available to other locations in the network. The DICOM Video is indicated to receive studies in

various digital formats (text, still images and video) or digitized video signals from acquisition

host devices. The device operations include capturing the data, recording, storing, editing and

transferring it to the clinic PACS as DICOM files.

Indications for use as stated in the FDA summary.

Also cleared against K000411

3 other devices cite the same predicate.

  • K033870Image Management SystemWelch Allyn, Inc. · 2004
  • K013631Efilm VideoEfilm Medical, Inc. · 2001
  • K013395Lifejet Video LinkFerrania S.P.A. · 2001

Recent decisions in LMA

The LMA category page

  • K130636Teleradpro Edge; Teleradpro Edge HD-CCDVidar Systems Corp. · 2013
  • K130406Diagnosticpro EdgeVidar Systems Corp. · 2013
  • K102476TeleradproVidar Systems Corp. · 2010
  • K093809Vidar Dental Film DigitizerVidar Systems Corp. · 2010
  • K091288Medi-6000 Medical Image DigitizerMicrotek International, Inc. · 2009

https://510kreport.com/device/K132183 · printed Nov 6, 2026

Cite this page

510(k) Report. “K132183: Dicom Video.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132183

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026