510(k) Report

510(k) · Cleared

Recalled · 2009

Compax Model 40, 400, 400T

K884930510(k) TraditionalCleared Dec 22, 198827-day reviewClass II21 CFR 892.1980Recalls 1

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

General Electric Co. · IZZ Table, Radiographic, Non-Tilting, Powered

Cleared on Dec 22, 1988 after a 27-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 293 later devices descend from it. It has been recalled once.

Decided
Dec 22, 1988
Review
27 days
Class
Class II
Product code
IZZ
Recalls
1
Predicates
0

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

Descendants, by year cleared 1999: 3 descendants cleared1997: 1 descendant cleared2001: 3 descendants cleared2006: 3 descendants cleared2005: 4 descendants cleared2013: 14 descendants cleared2016: 20 descendants cleared2009: 5 descendants cleared2012: 12 descendants cleared2010: 10 descendants cleared2007: 4 descendants cleared2002: 1 descendant cleared2019: 20 descendants cleared2015: 20 descendants cleared2008: 6 descendants cleared2011: 11 descendants cleared2014: 17 descendants cleared2003: 1 descendant cleared2020: 17 descendants cleared2017: 15 descendants cleared2018: 20 descendants cleared2024: 14 descendants cleared2022: 20 descendants cleared2021: 16 descendants cleared2025: 14 descendants cleared2026: 11 descendants cleared2023: 11 descendants cleared1990200020102020
  1. This deviceK884930 Compax Model 40, 400, 400TGeneral Electric Co. · 1988
  2. Descendant · cites it directly · 197 of its ownK971452 Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997 · Recalled
  3. Descendant · 2 generations on · 187 of its ownK983732 Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · Recalled
  4. Descendant · cites it directly · 104 of its ownK992066 Revolution TX/I Digital Radiographic Table SystemGE Medical Systems · 1999
  5. Descendant · 2 generations on · 103 of its ownK012389 Revolution XR/D Digital Radiographic Imaging SystemGe Medical Systems, Inc. · 2001 · Recalled
  6. Descendant · 3 generations on · 103 of its ownK992794 Stingray DR, Model 1Infimed, Inc. · 1999

Showing 5 of 293 descendants. See all descendants

Descendants cleared per year

1997: 11999: 32001: 32002: 12003: 12005: 42006: 32007: 42008: 62009: 52010: 102011: 112012: 122013: 142014: 172015: 202016: 202017: 152018: 202019: 202020: 172021: 162022: 202023: 112024: 142025: 142026: 11
1997high 20 (2015) · low 0 (1998)2026

Most influential descendants

Showing 5 of 293 · See all
  • K971452Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997 · cites it directly197descendants
  • K983732Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · 2 generations on187descendants
  • K992066Revolution TX/I Digital Radiographic Table SystemGE Medical Systems · 1999 · cites it directly104descendants
  • K012389Revolution XR/D Digital Radiographic Imaging SystemGe Medical Systems, Inc. · 2001 · 2 generations on103descendants
  • K992794Stingray DR, Model 1Infimed, Inc. · 1999 · 3 generations on103descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K884930Compax Model 40, 400, 400TGeneral Electric Co.1988—
+1K971452Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc.19978
+2K983732Thorax FD and Multix FDSiemens Medical Solutions USA, Inc.19991
+1K992066Revolution TX/I Digital Radiographic Table SystemGE Medical Systems1999—
+2K012389Revolution XR/D Digital Radiographic Imaging SystemGe Medical Systems, Inc.20014
+3K992794Stingray DR, Model 1Infimed, Inc.1999—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199930
200130
200210
200310
200540
200630
200740
200860
200950
2010100
2011110
2012120
2013140
2014170
2015200
2016200
2017150
2018200
2019200
2020170
2021160
2022200
2023110
2024140
2025140
2026110
FIG. 1 — Lineage of K884930, 1988–2026Source: 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 IZZ? 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? (293)

See all 293

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

NumberDeviceApplicantDecidedDescendants
K971452Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc.1997197
K992066Revolution TX/I Digital Radiographic Table SystemGE Medical Systems1999104

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jul 30, 2009Not classifiedZ-0457-2010OtherGE Healthcare has recently become aware that table lock safety features, which are provided with Compax 40E X-ray systems, are not always being utilized and has resulted in unintended lateral tabletop movement that may impact patient…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K971452 (Siemens Medical Solutions USA, Inc., 1997) has gone furthest, with 197 descendants of its own.

How does its category compare?

All IZZ devices

IZZ Table, Radiographic, Non-Tilting, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IZZ

FDA has decided no IZZ device since 2007.

Median 510(k) review, days · IZZ

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

Recalls per year · IZZ

1in 2018

2009: 12018: 1
2007high 1 (2009) · low 0 (2007)2026

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

Adverse event reports per year · IZZ

2in 2025

2007: 12008: 352009: 202011: 42012: 42013: 42014: 32016: 12019: 12020: 22021: 22022: 12023: 12024: 12025: 2
2007high 35 (2008) · low 0 (2010)2025

MAUDE reports naming product code IZZ, 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—01
20080—035
20090—120
20100—00
20110—04
20120—04
20130—04
20140—03
20150—00
20160—01
20170—00
20180—10
20190—01
20200—02
20210—02
20220—01
20230—01
20240—01
20250—02
20260—0—
Cite this page

510(k) Report. “K884930: Compax Model 40, 400, 400T.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K884930

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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