510(k) · Cleared
ClearedMULTIX Impact E
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions · KPR System, X-Ray, Stationary
Cleared on Nov 29, 2023 as substantially equivalent to K220919 (Siemens Medical Solutions USA, Inc., 2022) after a 27-day review. Its family tree reaches back 16 generations to 1980.
- Decided
- Nov 29, 2023
- Review
- 27 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K801623 (1980). 72 ancestors in all. No later device cites it as a predicate yet.
- Root · 16 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 12 generations between
- 3 generations backK193089 MULTIX ImpactSiemens Medical Solutions USA, Inc. · 2020
- 2 generations backK203345 MULTIX ImpactSiemens Medical Solutions USA, Inc. · 2021
- 1 generation backK220919 MULTIX Impact ESiemens Medical Solutions USA, Inc. · 2022
- This deviceK233532 MULTIX Impact ESiemens Medical Solutions · 2023
Show all 16 generations
- Root · 16 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 15 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 14 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 13 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 12 generations backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- 11 generations backK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 10 generations backK061054 Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 9 generations backK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- 8 generations backK081722 YSIOSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- 7 generations backK121513 Multix FusionSiemens Medical Solution · 2012 · Recalled
- 6 generations backK142049 Multix Fusion VA30 & VA40Siemens Medical Solutions USA, Inc. · 2014
- 5 generations backK162971 Multix Fusion MaxSiemens Medical Solutions USA, Inc. · 2016
- 4 generations backK182517 MULTIX ImpactSiemens Medi Cal Solutions, Inc. · 2019
- 3 generations backK193089 MULTIX ImpactSiemens Medical Solutions USA, Inc. · 2020
- 2 generations backK203345 MULTIX ImpactSiemens Medical Solutions USA, Inc. · 2021
- 1 generation backK220919 MULTIX Impact ESiemens Medical Solutions USA, Inc. · 2022
- This deviceK233532 MULTIX Impact ESiemens Medical Solutions · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −15 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −14 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −13 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −12 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| −11 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| −10 | K061054 | Axiom Aristos FX Plus | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| −9 | K062623 | Axiom Luminos DRF | Siemens Medical Solutions USA, Inc. | 2007 | 20 |
| −8 | K081722 | YSIO | Siemens Medical Solutions USA, Inc. | 2008 | 11 |
| −7 | K121513 | Multix Fusion | Siemens Medical Solution | 2012 | 4 |
| −6 | K142049 | Multix Fusion VA30 & VA40 | Siemens Medical Solutions USA, Inc. | 2014 | — |
| −5 | K162971 | Multix Fusion Max | Siemens Medical Solutions USA, Inc. | 2016 | — |
| −4 | K182517 | MULTIX Impact | Siemens Medi Cal Solutions, Inc. | 2019 | — |
| −3 | K193089 | MULTIX Impact | Siemens Medical Solutions USA, Inc. | 2020 | — |
| −2 | K203345 | MULTIX Impact | Siemens Medical Solutions USA, Inc. | 2021 | — |
| −1 | K220919 | MULTIX Impact E | Siemens Medical Solutions USA, Inc. | 2022 | — |
| 0 (this device) | K233532 | MULTIX Impact E | Siemens Medical Solutions | 2023 | — |
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 |
| 2014 | 1 | 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.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 43 years and passes through 8 companies; a new generation was cleared every 1.5 years on median.
- 21 of the 72 ancestors have a recall of any class.
- 1 other device also cites its predicate K220919.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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?
MULTIX Impact E is a radiographic system used in hospitals, clinics, and medical practices.
MULTIX Impact E enables radiographic exposures of the whole body including: skull, chest, abdomen, and extremities and may be used on pediatric, adult and obese patients. Exposures may be taken with the patient sitting, standing, or in the prone position.
MULTIX Impact E uses digital detectors for generating diagnostic images by converting X- rays into image signals.
MULTIX Impact E is also designed to be used with conventional film/screen or Computed Radiography (CR) cassettes.
MULTIX Impact E is not intended for mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233532 · printed Nov 4, 2026
Cite this page
510(k) Report. “K233532: MULTIX Impact E.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K233532
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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