510(k) Report

510(k) · Cleared

Recalled · Class II · 2024

Multix Top/Pro Radiographic X-Ray Table

K971452510(k) TraditionalCleared May 14, 199723-day reviewClass II21 CFR 892.1980Recalls 8

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

Siemens Medical Solutions USA, Inc. · IZZ Table, Radiographic, Non-Tilting, Powered

Cleared on May 14, 1997 as substantially equivalent to K803130 (Siemens Corp., 1981) and 1 other predicate after a 23-day review. Its family tree reaches back 1 generation to 1981. 197 later devices descend from it. It has been recalled 8 times.

Decided
May 14, 1997
Review
23 days
Class
Class II
Product code
IZZ
Recalls
8
Predicates
2

Its longest line of descent runs back 1 generation to K803130 (1981). 2 ancestors in all. 197 later devices descend from it, 3 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1988: 1 other ancestor2001: 1 descendant cleared1999: 2 descendants cleared2006: 3 descendants cleared2010: 9 descendants cleared2007: 4 descendants cleared2005: 1 descendant cleared2002: 1 descendant cleared2013: 11 descendants cleared2012: 7 descendants cleared2008: 6 descendants cleared2016: 13 descendants cleared2003: 1 descendant cleared2009: 4 descendants cleared2011: 9 descendants cleared2015: 12 descendants cleared2020: 14 descendants cleared2017: 10 descendants cleared2018: 8 descendants cleared2022: 9 descendants cleared2019: 14 descendants cleared2014: 12 descendants cleared2024: 7 descendants cleared2026: 8 descendants cleared2025: 9 descendants cleared2023: 8 descendants cleared2021: 14 descendants clearedK803130 · Multix U. Bucky Table X-Ray Unit · Siemens Corp. · 1981 · recalled19801990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 3 descendants2 generations forward: 6 descendants3 generations forward: 8 descendants4 generations forward: 19 descendants5 generations forward: 32 descendants6 generations forward: 38 descendants7 generations forward: 39 descendants8 generations forward: 23 descendants9 generations forward: 12 descendants10 generations forward: 7 descendants11 generations forward: 5 descendants12 generations forward: 5 descendants K803130 · Multix U. Bucky Table X-Ray Unit · Siemens Corp. · 1981 · recalled0+5+10
  1. Root · 1 generation backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
  2. This deviceK971452 Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997
  3. Descendant · cites it directly · 187 of its ownK983732 Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · Recalled
  4. Descendant · 2 generations on · 103 of its ownK992794 Stingray DR, Model 1Infimed, Inc. · 1999
  5. Descendant · 2 generations on · 81 of its ownK013826 Axiom Aristos FX (Multi Purpose Radiography System)Siemens Medical Systems, Inc. · 2002 · Recalled
  6. Descendant · 3 generations on · 80 of its ownK061054 Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · Recalled
  7. Descendant · 4 generations on · 78 of its ownK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · Recalled

Showing 5 of 197 descendants. See all descendants

Descendants cleared per year

1999: 22001: 12002: 12003: 12005: 12006: 32007: 42008: 62009: 42010: 92011: 92012: 72013: 112014: 122015: 122016: 132017: 102018: 82019: 142020: 142021: 142022: 92023: 82024: 72025: 92026: 8
1999high 14 (2019) · low 0 (2000)2026

Most influential descendants

Showing 5 of 197 · See all
  • K983732Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · cites it directly187descendants
  • K992794Stingray DR, Model 1Infimed, Inc. · 1999 · 2 generations on103descendants
  • K013826Axiom Aristos FX (Multi Purpose Radiography System)Siemens Medical Systems, Inc. · 2002 · 2 generations on81descendants
  • K061054Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · 3 generations on80descendants
  • K062623Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · 4 generations on78descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K803130Multix U. Bucky Table X-Ray UnitSiemens Corp.19811
0 (this device)K971452Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc.1997—
+1K983732Thorax FD and Multix FDSiemens Medical Solutions USA, Inc.19991
+2K992794Stingray DR, Model 1Infimed, Inc.1999—
+2K013826Axiom Aristos FX (Multi Purpose Radiography System)Siemens Medical Systems, Inc.20028
+3K061054Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc.20063
+4K062623Axiom Luminos DRFSiemens Medical Solutions USA, Inc.200720

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199920
200110
200210
200310
200510
200630
200740
200860
200940
201090
201190
201270
2013110
2014120
2015120
2016130
2017100
201880
2019140
2020140
2021140
202290
202380
202470
202590
202680
FIG. 1 — Lineage of K971452, 1981–2026Source: 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), 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 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? (2)

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
*K803130Multix U. Bucky Table X-Ray Unit
Summary page 2
…lowing devices in commercial distribution: Simplified 510(k): Multix TOP/PRO Table Siemens Medical Systems, Inc. Pg. 56 of 57 il SIEMENS e Multix U/C, K803130 Siemens Medical Systems, Inc. o Compax 40E*, K884930 General Electric Co. * Please note, it is believed the GE Compax 40E is des…
Siemens Corp.19811
*K884930Compax Model 40, 400, 400T
Summary page 2
…d 510(k): Multix TOP/PRO Table Siemens Medical Systems, Inc. Pg. 56 of 57 il SIEMENS e Multix U/C, K803130 Siemens Medical Systems, Inc. o Compax 40E*, K884930 General Electric Co. * Please note, it is believed the GE Compax 40E is described in the FDA Clearance for the GE Compax 40 unde…
General Electric Co.19881

What descends from it? (197)

See all 197

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

NumberDeviceApplicantDecidedDescendants
K983732Thorax FD and Multix FDSiemens Medical Solutions USA, Inc.1999187
K063421DX-SIAgfa Corp.20066
K013218Fuji Speed Suite, Fuji Speed Sute Phase IIFujifilm Medical System U.S.A., Inc.20011

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

Recalls of this device

DateClassRecallRoot causeReason
May 31, 2024Class IIZ-2180-2024Under Investigation by firmShort circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
May 31, 2024Class IIZ-2186-2024Under Investigation by firmShort circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
May 31, 2024Class IIZ-2183-2024Under Investigation by firmShort circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
May 31, 2024Class IIZ-2187-2024Under Investigation by firmShort circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
May 31, 2024Class IIZ-2182-2024Under Investigation by firmShort circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
May 31, 2024Class IIZ-2181-2024Under Investigation by firmShort circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire
Aug 6, 2018Class IIZ-0298-2019Device DesignIn rare cases of high clinical workload, the steel cables inside the lifting column of the overhead tube, which are designed to take the load, may rapture without triggering the safety lock. This could lead to overloading the safety rope…
Mar 5, 2014Class IIZ-1460-2014Component design/selectionThere is a potential issue and possible hazard to patients when using the AXIOM Vertix MD Trauma systems. In rare cases, steel ropes inside the lift column of the system can be defective without triggering the safety lock, which can…

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • 2 of the 2 ancestors have a recall of any class.
  • Of its descendants, K983732 (Siemens Medical Solutions USA, Inc., 1999) has gone furthest, with 187 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—

What is it indicated for?

The Multix TOP/ PRO Radiographic X-ray Table is a patient table used in conjunction with the Siemens Multix PRO - and TOP Systems radiographic devices. The table allows for radiographic exposures of the entire body, specifically the skull, spinal column, chest and abdomen, as well as the extremities. Applications can be performed with sitting, standing or prone patient positioning.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Cite this page

510(k) Report. “K971452: Multix Top/Pro Radiographic X-Ray Table.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K971452

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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