510(k) · Cleared
Recalled · Class II · 2024Multix Top/Pro Radiographic X-Ray Table
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
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.
- Root · 1 generation backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- This deviceK971452 Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997
- Descendant · cites it directly · 187 of its ownK983732 Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- Descendant · 2 generations on · 103 of its ownK992794 Stingray DR, Model 1Infimed, Inc. · 1999
- Descendant · 2 generations on · 81 of its ownK013826 Axiom Aristos FX (Multi Purpose Radiography System)Siemens Medical Systems, Inc. · 2002 · Recalled
- Descendant · 3 generations on · 80 of its ownK061054 Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 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
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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K803130 | Multix U. Bucky Table X-Ray Unit | Siemens Corp. | 1981 | 1 |
| 0 (this device) | K971452 | Multix Top/Pro Radiographic X-Ray Table | Siemens Medical Solutions USA, Inc. | 1997 | — |
| +1 | K983732 | Thorax FD and Multix FD | Siemens Medical Solutions USA, Inc. | 1999 | 1 |
| +2 | K992794 | Stingray DR, Model 1 | Infimed, Inc. | 1999 | — |
| +2 | K013826 | Axiom Aristos FX (Multi Purpose Radiography System) | Siemens Medical Systems, Inc. | 2002 | 8 |
| +3 | K061054 | Axiom Aristos FX Plus | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| +4 | K062623 | Axiom Luminos DRF | Siemens Medical Solutions USA, Inc. | 2007 | 20 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2007 | 4 | 0 |
| 2008 | 6 | 0 |
| 2009 | 4 | 0 |
| 2010 | 9 | 0 |
| 2011 | 9 | 0 |
| 2012 | 7 | 0 |
| 2013 | 11 | 0 |
| 2014 | 12 | 0 |
| 2015 | 12 | 0 |
| 2016 | 13 | 0 |
| 2017 | 10 | 0 |
| 2018 | 8 | 0 |
| 2019 | 14 | 0 |
| 2020 | 14 | 0 |
| 2021 | 14 | 0 |
| 2022 | 9 | 0 |
| 2023 | 8 | 0 |
| 2024 | 7 | 0 |
| 2025 | 9 | 0 |
| 2026 | 8 | 0 |
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
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K803130 | Multix U. Bucky Table X-Ray UnitSummary 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… | 1981 |
| * | K884930 | Compax Model 40, 400, 400TSummary 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… | 1988 |
What descends from it? (197)
See all 1973 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 31, 2024 | Class II | Z-2180-2024 | Under Investigation by firm | Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire |
| May 31, 2024 | Class II | Z-2186-2024 | Under Investigation by firm | Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire |
| May 31, 2024 | Class II | Z-2183-2024 | Under Investigation by firm | Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire |
| May 31, 2024 | Class II | Z-2187-2024 | Under Investigation by firm | Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire |
| May 31, 2024 | Class II | Z-2182-2024 | Under Investigation by firm | Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire |
| May 31, 2024 | Class II | Z-2181-2024 | Under Investigation by firm | Short circuit in the power supply unit (PSU) of the Touch Display may lead to overheating and fire |
| Aug 6, 2018 | Class II | Z-0298-2019 | Device Design | In 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, 2014 | Class II | Z-1460-2014 | Component design/selection | There 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… |
The 5 latest of 8 recalls; the web page lists all.
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 devicesIZZ 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
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZZ
2in 2025
MAUDE reports naming product code IZZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 35 |
| 2009 | 0 | — | 1 | 20 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 0 | 3 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 1 | 0 |
| 2019 | 0 | — | 0 | 1 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 1 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 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.
https://510kreport.com/device/K971452 · printed Nov 4, 2026
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