510(k) · Cleared
Recalled · Class II · 2020Axiom Aristos FX Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on May 9, 2006 as substantially equivalent to K013826 (Siemens Medical Systems, Inc., 2002) and 1 other predicate after a 22-day review. Its family tree reaches back 6 generations to 1980. 80 later devices descend from it. It has been recalled 3 times.
- Decided
- May 9, 2006
- Review
- 22 days
- Class
- Class II
- Product code
- MQB
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 6 generations to K801623 (1980). 41 ancestors in all. 80 later devices descend from it, 4 citing it directly.
- Root · 6 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 5 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 4 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 3 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 2 generations backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- 1 generation backK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- This deviceK061054 Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006
- Descendant · cites it directly · 78 of its ownK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- Descendant · cites it directly · 43 of its ownK081722 YSIOSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- Descendant · 2 generations on · 32 of its ownK121513 Multix FusionSiemens Medical Solution · 2012 · Recalled
- Descendant · 2 generations on · 23 of its ownK133259 Ysio MaxSiemens Medical Solutions USA, Inc. · 2014 · Recalled
- Descendant · 3 generations on · 18 of its ownK142049 Multix Fusion VA30 & VA40Siemens Medical Solutions USA, Inc. · 2014
Showing 5 of 80 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 80 · See all- K062623Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · cites it directly78descendants
- K081722YSIOSiemens Medical Solutions USA, Inc. · 2008 · cites it directly43descendants
- K121513Multix FusionSiemens Medical Solution · 2012 · 2 generations on32descendants
- K133259Ysio MaxSiemens Medical Solutions USA, Inc. · 2014 · 2 generations on23descendants
- K142049Multix Fusion VA30 & VA40Siemens Medical Solutions USA, Inc. · 2014 · 3 generations on18descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −5 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −4 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −3 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −2 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| −1 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| 0 (this device) | K061054 | Axiom Aristos FX Plus | Siemens Medical Solutions USA, Inc. | 2006 | — |
| +1 | K062623 | Axiom Luminos DRF | Siemens Medical Solutions USA, Inc. | 2007 | 20 |
| +1 | K081722 | YSIO | Siemens Medical Solutions USA, Inc. | 2008 | 11 |
| +2 | K121513 | Multix Fusion | Siemens Medical Solution | 2012 | 4 |
| +2 | K133259 | Ysio Max | Siemens Medical Solutions USA, Inc. | 2014 | 7 |
| +3 | K142049 | Multix Fusion VA30 & VA40 | Siemens Medical Solutions USA, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1988 | 2 | 0 |
| 1991 | 3 | 0 |
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 10 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2002 | 3 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 MQB? 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 MQB device
- #1 K201528 Yushan X-Ray Flat Panel Detector with DROCscore 21.5 · 12 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 |
|---|---|---|---|
| * | K013826 | Axiom Aristos FX (Multi Purpose Radiography System)Summary page 2…he body. It is substantially equivalent to the following SIEMENS Medical Systems devices: AXIOM Aristos FX K013826, cleared on 2/4/02 The Wireless Remote Control is substantially equivalent to the wireless footswitch for… | 2002 |
| * | K052202 | Axiom Artis - Modular Angiographic SystemSummary page 2…te Control is substantially equivalent to the wireless footswitch for AXIOM Artis system. AXIOM Artis with Wireless Footswitch K052202, cleared on 3/7/06 A detailed Substantial Equivalence Comparison is provided in Section 5. 6. Summary of Te… | 2006 |
What descends from it? (80)
See all 804 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 |
|---|---|---|---|---|
| Apr 6, 2020 | Class II | Z-1765-2020 | 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… |
| Dec 12, 2011 | Not classified | Z-0860-2012 | Process control | Fixation bolts for the mounting of the X-ray tube holder became mixed with an incorrect bolt type. |
| 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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 5 companies; a new generation was cleared every 2.0 years on median.
- 7 of the 41 ancestors have a recall of any class.
- Of its descendants, K062623 (Siemens Medical Solutions USA, Inc., 2007) has gone furthest, with 78 descendants of its own.
How does its category compare?
All MQB devicesMQB Solid State X-Ray Imager (Flat Panel/Digital Imager): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MQB
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQB
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQB
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQB
141in 2025
MAUDE reports naming product code MQB, 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 | 13 | 22 | 15 | 25 |
| 2008 | 8 | 15 | 36 | 30 |
| 2009 | 15 | 57 | 19 | 34 |
| 2010 | 11 | 116 | 14 | 39 |
| 2011 | 24 | 102 | 10 | 101 |
| 2012 | 22 | 80 | 8 | 267 |
| 2013 | 21 | 105 | 6 | 159 |
| 2014 | 32 | 102 | 0 | 29 |
| 2015 | 21 | 81 | 0 | 21 |
| 2016 | 22 | 92 | 0 | 26 |
| 2017 | 31 | 30 | 1 | 20 |
| 2018 | 16 | 30 | 4 | 84 |
| 2019 | 22 | 30 | 1 | 45 |
| 2020 | 19 | 28 | 4 | 9 |
| 2021 | 21 | 48 | 1 | 26 |
| 2022 | 31 | 48 | 0 | 13 |
| 2023 | 10 | 30 | 0 | 51 |
| 2024 | 8 | 187 | 0 | 91 |
| 2025 | 8 | 127 | 1 | 141 |
| 2026 | 3 | 245 | 1 | — |
What is it indicated for?
AXIOM Aristos FX Plus 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 AXIOM Aristos FX Plus 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 lying 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 as stated in the FDA summary.
https://510kreport.com/device/K061054 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061054: Axiom Aristos FX Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061054
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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