510(k) · Cleared
Recalled · Class II · 2022YSIO
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · KPR System, X-Ray, Stationary
Cleared on Aug 22, 2008 as substantially equivalent to K061054 (Siemens Medical Solutions USA, Inc., 2006) and 2 other predicates after a 65-day review. Its family tree reaches back 8 generations to 1980. 43 later devices descend from it. It has been recalled 11 times.
- Decided
- Aug 22, 2008
- Review
- 65 days
- Class
- Class II
- Product code
- KPR
- Recalls
- 11
- Predicates
- 4
Its longest line of descent runs back 8 generations to K801623 (1980). 63 ancestors in all. 43 later devices descend from it, 7 citing it directly.
- Root · 8 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 7 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 6 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 5 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 4 generations backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- 3 generations backK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 2 generations backK061054 Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 1 generation backK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- This deviceK081722 YSIOSiemens Medical Solutions USA, Inc. · 2008
- Descendant · cites it directly · 32 of its ownK121513 Multix FusionSiemens Medical Solution · 2012 · Recalled
- Descendant · cites it directly · 23 of its ownK133259 Ysio MaxSiemens Medical Solutions USA, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 18 of its ownK142049 Multix Fusion VA30 & VA40Siemens Medical Solutions USA, Inc. · 2014
- Descendant · 3 generations on · 10 of its ownK162971 Multix Fusion MaxSiemens Medical Solutions USA, Inc. · 2016
- Descendant · 4 generations on · 8 of its ownK182517 MULTIX ImpactSiemens Medi Cal Solutions, Inc. · 2019
Showing 5 of 43 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 43 · See all- K121513Multix FusionSiemens Medical Solution · 2012 · cites it directly32descendants
- K133259Ysio MaxSiemens Medical Solutions USA, Inc. · 2014 · cites it directly23descendants
- K142049Multix Fusion VA30 & VA40Siemens Medical Solutions USA, Inc. · 2014 · 2 generations on18descendants
- K162971Multix Fusion MaxSiemens Medical Solutions USA, Inc. · 2016 · 3 generations on10descendants
- K182517MULTIX ImpactSiemens Medi Cal Solutions, Inc. · 2019 · 4 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −7 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −6 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −5 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −4 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| −3 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| −2 | K061054 | Axiom Aristos FX Plus | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| −1 | K062623 | Axiom Luminos DRF | Siemens Medical Solutions USA, Inc. | 2007 | 20 |
| 0 (this device) | K081722 | YSIO | Siemens Medical Solutions USA, Inc. | 2008 | — |
| +1 | K121513 | Multix Fusion | Siemens Medical Solution | 2012 | 4 |
| +1 | K133259 | Ysio Max | Siemens Medical Solutions USA, Inc. | 2014 | 7 |
| +2 | K142049 | Multix Fusion VA30 & VA40 | Siemens Medical Solutions USA, Inc. | 2014 | — |
| +3 | K162971 | Multix Fusion Max | Siemens Medical Solutions USA, Inc. | 2016 | — |
| +4 | K182517 | MULTIX Impact | Siemens Medi Cal Solutions, Inc. | 2019 | — |
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 |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 1 | 0 |
| 2018 | 3 | 0 |
| 2019 | 6 | 0 |
| 2020 | 4 | 0 |
| 2021 | 3 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 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? (4)
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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K983732 | FDA’s K983732 is Thorax FD and Multix FD Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1999 |
| * | K061054 | Axiom Aristos FX PlusSummary page 2…following STEMENS Medical Systems devices: _510(!() Number Date of Clearance Device Name ‘ KY83732 April 21, 1999 Thorax FD and Multix FD (AXIOM Aristos TX / MX) K061054 May 09, 2006 AXIOM Aristos FX Plus (Wircless Remote) K062623 August 22, 2007 AXIOM Luminos dRF Many of the components used… | 2006 |
| * | K062623 | Axiom Luminos DRFSummary page 2…e of Clearance Device Name ‘ KY83732 April 21, 1999 Thorax FD and Multix FD (AXIOM Aristos TX / MX) K061054 May 09, 2006 AXIOM Aristos FX Plus (Wircless Remote) K062623 August 22, 2007 AXIOM Luminos dRF Many of the components used on the Ysio i.e. x-ray generator, x-ray tube, user interface, di… | 2007 |
| * | K070505 | Krystal-X WifiSummary page 2…uivalent to the wireless interface of the Krystal-X WiFi wireless digital X-ray sensor from Video Dental Concepts, Inc. 510{(k) Number Date of Clearance Device Name K070505 April 5, 2007 Krystal-X WiFi I A dectailed Substantial Equivalence Comparison is provided in Section 12. 510(k) Ysio Page 10… | 2007 |
What descends from it? (43)
See all 437 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 |
|---|---|---|---|---|
| Jan 31, 2022 | Class II | Z-0841-2022 | Software design | Siemens Healthineers has identified a software error in previous software version VB10 for the Ysio fully automated system. The unit may process incorrect internal values for the position of its ceiling tube stand. If the user activates a… |
| Feb 10, 2020 | Class II | Z-1501-2020 | Component design/selection | The Ysio system may process incorrect internal values for the position of its ceiling tube stand. If in this situation the user activates longitudinal or transversal stand movement (by using the buttons at the tube head or the remote… |
| Aug 6, 2018 | Class II | Z-0299-2019 | 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… |
| Aug 27, 2014 | Class II | Z-2680-2014 | Under Investigation by firm | Siemens discovered that an unlikely error may occur on the Ysio system with fixed detector in the wall stand. This error may result in line artifacts in the image. If these artifacts appear in the region of interest, the examination may… |
| Jul 7, 2014 | Class II | Z-2292-2014 | Device Design | It was discovered that during a RAD examination using Siemens Luminos dRF, Ysio or Uroskop Omnia systems with software version VB10C to VB10F and automatic exposure control, a highly unlikely malfunction can result in longer radiation… |
| May 9, 2014 | Class II | Z-1717-2014 | Use error | Excessive usage of cleaning liquid on Siemens Ysio Systems may cause infiltration of the generator console, which may lead to a short circuit causing an unintended release of radiation. |
| Sep 3, 2013 | Class II | Z-0374-2014 | Software design | A potential malfunction and hazard to patients exists when using the Ysio, Luminos Agile, Luminos dRF, and Uroskop Omnia systems with software version VC10, which may result in radiation continuing longer than required and overexposed… |
| Aug 28, 2013 | Class II | Z-1845-2014 | Software design | When using systems operating with software versions VD10A/G during a RAD examination, a malfunction can result in the image appearing very dark, which may prompt unnecessary repetition of the examination. |
| May 6, 2013 | Class II | Z-0016-2014 | Software design | Siemens has discovered through product monitoring a potential malfunction when using system operating with software versions VB10D, VB10F, VB10C and VB10. During a RAD examination the possibility exists that radiation may continue longer… |
| Feb 15, 2012 | Not classified | Z-1159-2012 | Software design | Firm has become aware of unintended behavior when using Ysio, AXIOM dRF, AXIOM Luminos Agile/TF and Uroskop Omnia with RAD Fluoro Uro function using software version VC10A. Due to an error in the image pipeline, images may display dark… |
| Apr 28, 2011 | Not classified | Z-2787-2011 | Other | There is a potential hazard to staff or patients when lowering the table height on the Ysio system. If staff or patients lower extremities are placed underneath the table and the user lowers the table top, it is possible that parts of the… |
The 5 latest of 11 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 28 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 18 of the 63 ancestors have a recall of any class.
- Of its descendants, K121513 (Siemens Medical Solution, 2012) has gone furthest, with 32 descendants of its own.
- 3 other devices also cite its predicate K061054.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Ysio (New RAD -FAMILY) systems are radiographic systems used in hospitals, clinics, and medical practices. Ysio enables radiographic and tomographic 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…
Read the full statement (117 words)
The Ysio (New RAD -FAMILY) systems are radiographic systems used in hospitals, clinics, and medical practices. Ysio enables radiographic and tomographic 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 Ysio system is not meant for mammography.
The Ysio uses an integrated or portable digital detector for generating diagnostic images by converting x-rays into electronic signals. Ysio is also designed to be used with conventional film/screen or Computed Radiography (CR) casseltes.
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/K081722 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081722: YSIO.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081722
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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