510(k) · Cleared
Recalled · Class II · 2018Multix Fusion
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solution · KPR System, X-Ray, Stationary
Cleared on Aug 10, 2012 as substantially equivalent to K081722 (Siemens Medical Solutions USA, Inc., 2008) after an 81-day review. Its family tree reaches back 9 generations to 1980. 32 later devices descend from it. It has been recalled 4 times.
- Decided
- Aug 10, 2012
- Review
- 81 days
- Class
- Class II
- Product code
- KPR
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 9 generations to K801623 (1980). 64 ancestors in all. 32 later devices descend from it, 6 citing it directly.
- Root · 9 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 5 generations between
- 3 generations backK061054 Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 2 generations backK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- 1 generation backK081722 YSIOSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- This deviceK121513 Multix FusionSiemens Medical Solution · 2012
- Descendant · cites it directly · 18 of its ownK142049 Multix Fusion VA30 & VA40Siemens Medical Solutions USA, Inc. · 2014
- Descendant · 2 generations on · 10 of its ownK162971 Multix Fusion MaxSiemens Medical Solutions USA, Inc. · 2016
- Descendant · 3 generations on · 8 of its ownK182517 MULTIX ImpactSiemens Medi Cal Solutions, Inc. · 2019
- Descendant · 4 generations on · 7 of its ownK193089 MULTIX ImpactSiemens Medical Solutions USA, Inc. · 2020
- Descendant · 2 generations on · 6 of its ownK162529 DigiX FDXAllengers Medical Systems Limited · 2017
Show all 9 generations
- Root · 9 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 8 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 7 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 6 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 5 generations backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- 4 generations backK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 3 generations backK061054 Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 2 generations backK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- 1 generation backK081722 YSIOSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- This deviceK121513 Multix FusionSiemens Medical Solution · 2012
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K142049Multix Fusion VA30 & VA40Siemens Medical Solutions USA, Inc. · 2014 · cites it directly18descendants
- K162971Multix Fusion MaxSiemens Medical Solutions USA, Inc. · 2016 · 2 generations on10descendants
- K182517MULTIX ImpactSiemens Medi Cal Solutions, Inc. · 2019 · 3 generations on8descendants
- K193089MULTIX ImpactSiemens Medical Solutions USA, Inc. · 2020 · 4 generations on7descendants
- K162529DigiX FDXAllengers Medical Systems Limited · 2017 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −8 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −7 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −6 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −5 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| −4 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| −3 | K061054 | Axiom Aristos FX Plus | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| −2 | K062623 | Axiom Luminos DRF | Siemens Medical Solutions USA, Inc. | 2007 | 20 |
| −1 | K081722 | YSIO | Siemens Medical Solutions USA, Inc. | 2008 | 11 |
| 0 (this device) | K121513 | Multix Fusion | Siemens Medical Solution | 2012 | — |
| +1 | K142049 | Multix Fusion VA30 & VA40 | Siemens Medical Solutions USA, Inc. | 2014 | — |
| +2 | K162971 | Multix Fusion Max | Siemens Medical Solutions USA, Inc. | 2016 | — |
| +3 | K182517 | MULTIX Impact | Siemens Medi Cal Solutions, Inc. | 2019 | — |
| +4 | K193089 | MULTIX Impact | Siemens Medical Solutions USA, Inc. | 2020 | — |
| +2 | K162529 | DigiX FDX | Allengers Medical Systems Limited | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 2 | 0 |
| 1995 | 13 | 0 |
| 1996 | 4 | 0 |
| 1997 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 5 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2019 | 5 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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? (1)
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 |
|---|---|---|---|
| * | K081722 | YSIOSummary page 2…Product Code: 90 KPR 4. Legally Marketed Predicate Device Trade Name: Ysio 510(k) #: K081 7227 Clearance Date: August 22, 2008 Classification Name: Solid State X-ray Imager (SSXI)… | 2008 |
What descends from it? (32)
See all 326 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142049 | Multix Fusion VA30 & VA40 | 2014 | 18 |
| K132934 | Multix Select DR | 2014 | 3 |
| K160620 | Visaris Vision® (Vision C, Vision U. Vision V, Vision X) | 2016 | 2 |
| K153119 | Amrad Medical OTS Digital Radiography System, Amrad Medical DFMTS Digital Radiography… | 2016 | 2 |
| K152767 | OTC12D Auto Radiographic System | 2015 | 1 |
| K150663 | Diagnostic X-ray System | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 3, 2018 | Class II | Z-0297-2019 | Device Design | Steel cables inside the lifting column of the overhead tube, may rapture without triggering the safety lock, leading to mechanical fatigue and cause the arm to drop down unexpectedly during movement in vertical direction and during… |
| Aug 1, 2016 | Class II | Z-0013-2017 | Process control | Siemens became aware of a potential issue with the patient table for Ysio Max and Multix Fusion systems. There is an unlikely risk that an internal part of the table may detach causing the table top to tilt to the left side which could… |
| Aug 1, 2016 | Class II | Z-0014-2017 | Process control | Siemens became aware of a potential issue with the patient table for Ysio Max and Multix Fusion systems. There is an unlikely risk that an internal part of the table may detach causing the table top to tilt to the left side which could… |
| Feb 13, 2014 | Class II | Z-1505-2014 | Process change control | It was observed that the corrugated hose holder above the 3D rail on the Multix Fusion system became loose. According to the Installation Instructions the corrugated hose holder shall be afixed with transversal carriage, with Loctite 243… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 32 years and passes through 6 companies; a new generation was cleared every 1.5 years on median.
- 19 of the 64 ancestors have a recall of any class.
- Of its descendants, K142049 (Siemens Medical Solutions USA, Inc., 2014) has gone furthest, with 18 descendants of its own.
- 6 other devices also cite its predicate K081722.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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?
The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient…
Read the full statement (121 words)
The Multix Fusion system is a radiographic system used in hospitals, clinics, and medical practices. Multix Fusion enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and bariatric patients. It can also be used for intravenous, small interventions (like biopsy, punctures, etc.) and emergency (trauma, critical ill) applications. Exposures may be taken with the patient sitting, standing, or in the prone position. The Multix Fusion system is not meant for mammography.
The Multix Fusion uses a mobile (wired) or portable (wireless) digital detector for generating diagnostic images by converting x-rays into electronic signals. The Multix Fusion is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121513 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121513: Multix Fusion.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121513
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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