510(k) Report

510(k) · Cleared

Cleared

Doosan DSP 3800 Automatic X-Ray Film Processor

K954345510(k) TraditionalCleared Oct 18, 199530-day reviewClass II21 CFR 892.1900

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

Doosan Corp. · IXW Processor, Radiographic-Film, Automatic

Cleared on Oct 18, 1995 after a 30-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.

Decided
Oct 18, 1995
Review
30 days
Class
Class II
Product code
IXW
Recalls
None
Predicates
0

4 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2009: 1 descendant cleared2003: 2 descendants cleared1995200020052010201520202025
  1. This deviceK954345 Doosan DSP 3800 Automatic X-Ray Film ProcessorDoosan Corp. · 1995
  2. Descendant · cites it directly · 2 of its ownK992818 Optimax/ Compact 2Protec GmbH & Co. KG · 1999
  3. Descendant · cites it directly · 0 of its ownK091628 Optimax, Compact 2, Optimax 2010, EcomaxProtec GmbH & Co. KG · 2009
  4. Descendant · 2 generations on · 0 of its ownK023801 Film Processor, Model Life Ray Pro 1000S.a.I.E.P. S.R.L. · 2003
  5. Descendant · 2 generations on · 0 of its ownK023825 Film Processor, Model Life Ray Pro 2500S.a.I.E.P. S.R.L. · 2003

Most influential descendants

Showing 4 of 4 · See all
  • K992818Optimax/ Compact 2Protec GmbH & Co. KG · 1999 · cites it directly2descendants
  • K091628Optimax, Compact 2, Optimax 2010, EcomaxProtec GmbH & Co. KG · 2009 · cites it directly0descendants
  • K023801Film Processor, Model Life Ray Pro 1000S.a.I.E.P. S.R.L. · 2003 · 2 generations on0descendants
  • K023825Film Processor, Model Life Ray Pro 2500S.a.I.E.P. S.R.L. · 2003 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K954345Doosan DSP 3800 Automatic X-Ray Film ProcessorDoosan Corp.1995—
+1K992818Optimax/ Compact 2Protec GmbH & Co. KG1999—
+1K091628Optimax, Compact 2, Optimax 2010, EcomaxProtec GmbH & Co. KG2009—
+2K023801Film Processor, Model Life Ray Pro 1000S.a.I.E.P. S.R.L.2003—
+2K023825Film Processor, Model Life Ray Pro 2500S.a.I.E.P. S.R.L.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200320
200910
FIG. 1 — Lineage of K954345, 1995–2009Source: 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 IXW? 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (4)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K992818Optimax/ Compact 2Protec GmbH & Co. KG19992
K091628Optimax, Compact 2, Optimax 2010, EcomaxProtec GmbH & Co. KG20090

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, K992818 (Protec GmbH & Co. KG, 1999) has gone furthest, with 2 descendants of its own.

How does its category compare?

All IXW devices

IXW Processor, Radiographic-Film, Automatic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IXW

1in 2011

2009: 12010: 12011: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IXW

Too few IXW 510(k)s in any year since 2007 to give a median.

Recalls per year · IXW

No recall names IXW since 2007.

Adverse event reports per year · IXW

2in 2018

2008: 12009: 22014: 22015: 22016: 12017: 12018: 2
2007high 2 (2009) · low 0 (2007)2025

MAUDE reports naming product code IXW, 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—01
20091—02
20101—00
20111—00
20120—00
20130—00
20140—02
20150—02
20160—01
20170—01
20180—02
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

Recent decisions in IXW

The IXW category page

  • K111167Xtender Film Processor, Sprint Film Processor Model Xtender Model SprintVelopex International, Inc. · 2011
  • K093503Intrax Film ProcessorVelopex International, Inc. · 2010
  • K091628Optimax, Compact 2, Optimax 2010, EcomaxProtec GmbH & Co. KG · 2009
  • K024342Radiographic Film Processor, Models XP400 and XP1000Daito Co., Ltd. · 2003
  • K023825Film Processor, Model Life Ray Pro 2500S.a.I.E.P. S.R.L. · 2003

https://510kreport.com/device/K954345 · printed Nov 5, 2026

Cite this page

510(k) Report. “K954345: Doosan DSP 3800 Automatic X-Ray Film Processor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K954345

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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