510(k) · Cleared
Recalled · Class II · 2020Axiom Aristos FX (Multi Purpose Radiography System)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Systems, Inc. · KPR System, X-Ray, Stationary
Cleared on Feb 1, 2002 as substantially equivalent to K983732 (Siemens Medical Solutions USA, Inc., 1999) and 1 other predicate after a 74-day review. Its family tree reaches back 3 generations to 1981. 81 later devices descend from it. It has been recalled 8 times.
- Decided
- Feb 1, 2002
- Review
- 74 days
- Class
- Class II
- Product code
- KPR
- Recalls
- 8
- Predicates
- 2
Its longest line of descent runs back 3 generations to K803130 (1981). 6 ancestors in all. 81 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 2 generations backK971452 Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997 · Recalled
- 1 generation backK983732 Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- This deviceK013826 Axiom Aristos FX (Multi Purpose Radiography System)Siemens Medical Systems, Inc. · 2002
- Descendant · cites it directly · 80 of its ownK061054 Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- Descendant · 2 generations on · 78 of its ownK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 43 of its ownK081722 YSIOSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 32 of its ownK121513 Multix FusionSiemens Medical Solution · 2012 · Recalled
- Descendant · 3 generations on · 23 of its ownK133259 Ysio MaxSiemens Medical Solutions USA, Inc. · 2014 · Recalled
Showing 5 of 81 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 81 · See all- K061054Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · cites it directly80descendants
- K062623Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · 2 generations on78descendants
- K081722YSIOSiemens Medical Solutions USA, Inc. · 2008 · 2 generations on43descendants
- K121513Multix FusionSiemens Medical Solution · 2012 · 3 generations on32descendants
- K133259Ysio MaxSiemens Medical Solutions USA, Inc. · 2014 · 3 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K803130 | Multix U. Bucky Table X-Ray Unit | Siemens Corp. | 1981 | 1 |
| −2 | K971452 | Multix Top/Pro Radiographic X-Ray Table | Siemens Medical Solutions USA, Inc. | 1997 | 8 |
| −1 | K983732 | Thorax FD and Multix FD | Siemens Medical Solutions USA, Inc. | 1999 | 1 |
| 0 (this device) | K013826 | Axiom Aristos FX (Multi Purpose Radiography System) | Siemens Medical Systems, Inc. | 2002 | — |
| +1 | K061054 | Axiom Aristos FX Plus | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| +2 | K062623 | Axiom Luminos DRF | Siemens Medical Solutions USA, Inc. | 2007 | 20 |
| +2 | K081722 | YSIO | Siemens Medical Solutions USA, Inc. | 2008 | 11 |
| +3 | K121513 | Multix Fusion | Siemens Medical Solution | 2012 | 4 |
| +3 | K133259 | Ysio Max | Siemens Medical Solutions USA, Inc. | 2014 | 7 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 4 | 0 |
| 2009 | 1 | 0 |
| 2010 | 4 | 0 |
| 2011 | 3 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 4 | 0 |
| 2015 | 5 | 0 |
| 2016 | 5 | 0 |
| 2017 | 2 | 0 |
| 2018 | 5 | 0 |
| 2019 | 6 | 0 |
| 2020 | 7 | 0 |
| 2021 | 5 | 0 |
| 2022 | 5 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 5 | 0 |
| 2026 | 4 | 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 KPR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new KPR device
- #1 K242119 Innovision-Exiiscore 17.0 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K983732 | Thorax FD and Multix FDSummary page 1…cate device. 4. Substantial Equivalence The MPRS stationary x-ray system is a modified version of the current, commercially available SIEMENS Medical Systems: Thorax FD K983732, cleared on 4/21/99 Multix FD K983732, cleared on 4/21/99 The table is a modified version of the Koordinat M , K951176, cleared… | 1999 |
| * | K951176 | Koordinat MSummary page 1…ally available SIEMENS Medical Systems: Thorax FD K983732, cleared on 4/21/99 Multix FD K983732, cleared on 4/21/99 The table is a modified version of the Koordinat M , K951176, cleared on 3/16/95 Information that substantiates this claim of equivalence is provided throughout this 510(k) submission and s… | 1995 |
What descends from it? (81)
See all 811 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061054 | Axiom Aristos FX Plus | 2006 | 80 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 6, 2020 | Class II | Z-1764-2020 | Radiation Control for Health and Safety Act | It was determined that in rare cases persons can receive low dose of unintended radiation. The system performed exposures without the exposure button being pressed. Exposure will be released for less than 500ms, therefore, the overall… |
| Apr 14, 2015 | Class II | Z-1583-2015 | Device Design | If the cable cart and the corrugated hose are unable to move freely, the cable holder could drop down and hit patients or system operators. |
| Feb 17, 2011 | Not classified | Z-1959-2011 | Other | During product monitoring, firm discovered a possible hazard to patients when using the detector alpha rotation of all Axiom Aristos FX and FX Plus systems with serial numbers up to and including 1216. When using the detector alpha… |
| Aug 25, 2008 | Not classified | Z-0163-2009 | Equipment maintenance | Tube support arm or the detecting mounting hardware may become loose at the joint with the telescope. |
| Jun 10, 2005 | Not classified | Z-0989-05 | Other | potential issue (system may lock up) when repeating patient registrations |
| Jun 10, 2005 | Not classified | Z-0990-05 | Other | potential issue (system may lock up) when repeating patient registrations |
| Jun 10, 2005 | Not classified | Z-0988-05 | Other | potential issue (system may lock up) when repeating patient registrations |
| Apr 19, 2003 | Not classified | Z-0984-03 | Other | software malfunction. May indicate that the image is flipped when it is not. |
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?
- The line of descent spans 21 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 4 of the 6 ancestors have a recall of any class.
- Of its descendants, K061054 (Siemens Medical Solutions USA, Inc., 2006) has gone furthest, with 80 descendants of its own.
- 3 other devices also cite its predicate K983732.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KPR
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPR
155in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPR
7in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPR
39in 2025
MAUDE reports naming product code KPR, 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 | 12 | 31 | 10 | 120 |
| 2008 | 15 | 48 | 10 | 95 |
| 2009 | 9 | 35 | 5 | 61 |
| 2010 | 9 | 126 | 3 | 82 |
| 2011 | 9 | 152 | 5 | 103 |
| 2012 | 11 | 58 | 1 | 74 |
| 2013 | 5 | 163 | 5 | 24 |
| 2014 | 10 | 108 | 8 | 34 |
| 2015 | 18 | 81 | 1 | 59 |
| 2016 | 11 | 84 | 4 | 18 |
| 2017 | 6 | 75 | 3 | 31 |
| 2018 | 15 | 30 | 4 | 36 |
| 2019 | 12 | 33 | 1 | 77 |
| 2020 | 16 | 39 | 1 | 41 |
| 2021 | 6 | 55 | 0 | 37 |
| 2022 | 8 | 43 | 2 | 27 |
| 2023 | 9 | 76 | 4 | 39 |
| 2024 | 11 | 162 | 1 | 34 |
| 2025 | 8 | 155 | 7 | 39 |
| 2026 | 6 | 197 | 0 | — |
What is it indicated for?
MPRS is a dedicated x-ray system with a flat panel detector, which allows the acquisition of x-ray exposures without the use of conventional film/screen systems. The MPRS allows radiographic exposures of the whole body including skull, spinal column, chest, abdomen, extremities, excluding mammography. Radiographic exposures may be taken with the patient in the sitting, standing, or supine positions. The intended use and indications for use of this modified device as described in its labeling have not changed from its predicate device.
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/K013826 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013826: Axiom Aristos FX (Multi Purpose Radiography System).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013826
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026