510(k) Report

510(k) · Cleared

Cleared

DFS-2100

K932760510(k) TraditionalCleared Oct 20, 1994499-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

Dba Systems, Inc. · LMA Digitizer, Image, Radiological

Cleared on Oct 20, 1994 after a 499-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.

Decided
Oct 20, 1994
Review
499 days
Class
Class II
Product code
LMA
Recalls
None
Predicates
0

3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2000: 1 descendant cleared2003: 1 descendant cleared2006: 1 descendant cleared1990200020102020
  1. This deviceK932760 DFS-2100Dba Systems, Inc. · 1994
  2. Descendant · cites it directly · 2 of its ownK992467 Imagclear Mammography Review SystemDba Systems, Inc. · 2000
  3. Descendant · 2 generations on · 1 of its ownK031132 Consultiva Case Input Station, Model Cis-1Eastman Kodak Company · 2003
  4. Descendant · 3 generations on · 0 of its ownK061160 M-VU Cad StationVucomp, Inc. · 2006

Most influential descendants

Showing 3 of 3 · See all
  • K992467Imagclear Mammography Review SystemDba Systems, Inc. · 2000 · cites it directly2descendants
  • K031132Consultiva Case Input Station, Model Cis-1Eastman Kodak Company · 2003 · 2 generations on1descendant
  • K061160M-VU Cad StationVucomp, Inc. · 2006 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K932760DFS-2100Dba Systems, Inc.1994—
+1K992467Imagclear Mammography Review SystemDba Systems, Inc.2000—
+2K031132Consultiva Case Input Station, Model Cis-1Eastman Kodak Company2003—
+3K061160M-VU Cad StationVucomp, Inc.2006—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200010
200310
200610
FIG. 1 — Lineage of K932760, 1994–2006Source: 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), 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?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K992467Imagclear Mammography Review SystemDba Systems, Inc.20002

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?

  • Of its descendants, K992467 (Dba Systems, Inc., 2000) has gone furthest, with 2 descendants of its own.

How does its category compare?

All LMA devices

LMA Digitizer, Image, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years.

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—

More from Dba Systems, Inc.

2 FDA decisions under this applicant name. See the company

  • K992467Imagclear Mammography Review SystemDba Systems, Inc. · 2000

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The LMA category page

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https://510kreport.com/device/K932760 · printed Nov 6, 2026

Cite this page

510(k) Report. “K932760: DFS-2100.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K932760

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026