510(k) · Cleared
Recalled · Class II · 2024Multitom Rax
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions · OWB Interventional Fluoroscopic X-Ray System
Cleared on Nov 17, 2022 as substantially equivalent to K212212 (Siemens Medical Solutions, 2022) after a 198-day review. Its family tree reaches back 9 generations to 1986. It has been recalled once.
- Decided
- Nov 17, 2022
- Review
- 198 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 9 generations to K862120 (1986). 14 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK862120 SCX SystemGeneral Electric Co. · 1986 · Recalled
- 5 generations between
- 3 generations backK142341 X-Ray TV System Sonialvision G4Shimadzu Corp. · 2015 · Recalled
- 2 generations backK190373 SonialVision G4Shimadzu Corporation · 2019 · Recalled
- 1 generation backK212212 Multitom Rax with True2scale Body Scan OptionSiemens Medical Solutions · 2022
- This deviceK221281 Multitom RaxSiemens Medical Solutions · 2022
Show all 9 generations
- Root · 9 generations backK862120 SCX SystemGeneral Electric Co. · 1986 · Recalled
- 8 generations backK982196 Digital Radiographic Imaging SystemGE Medical Systems · 1998
- 7 generations backK992066 Revolution TX/I Digital Radiographic Table SystemGE Medical Systems · 1999
- 6 generations backK012389 Revolution XR/D Digital Radiographic Imaging SystemGe Medical Systems, Inc. · 2001 · Recalled
- 5 generations backK051967 Revolution XR/D Digital Radiographic Imaging System with TomosynthesisGE Healthcare · 2005 · Recalled
- 4 generations backK132261 Discovery XR656 with Volumerad (Digital Tomosynthesis)Ge Medical Systems, LLC · 2013 · Recalled
- 3 generations backK142341 X-Ray TV System Sonialvision G4Shimadzu Corp. · 2015 · Recalled
- 2 generations backK190373 SonialVision G4Shimadzu Corporation · 2019 · Recalled
- 1 generation backK212212 Multitom Rax with True2scale Body Scan OptionSiemens Medical Solutions · 2022
- This deviceK221281 Multitom RaxSiemens Medical Solutions · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K862120 | SCX System | General Electric Co. | 1986 | 3 |
| −8 | K982196 | Digital Radiographic Imaging System | GE Medical Systems | 1998 | — |
| −7 | K992066 | Revolution TX/I Digital Radiographic Table System | GE Medical Systems | 1999 | — |
| −6 | K012389 | Revolution XR/D Digital Radiographic Imaging System | Ge Medical Systems, Inc. | 2001 | 4 |
| −5 | K051967 | Revolution XR/D Digital Radiographic Imaging System with Tomosynthesis | GE Healthcare | 2005 | 9 |
| −4 | K132261 | Discovery XR656 with Volumerad (Digital Tomosynthesis) | Ge Medical Systems, LLC | 2013 | 1 |
| −3 | K142341 | X-Ray TV System Sonialvision G4 | Shimadzu Corp. | 2015 | 2 |
| −2 | K190373 | SonialVision G4 | Shimadzu Corporation | 2019 | 2 |
| −1 | K212212 | Multitom Rax with True2scale Body Scan Option | Siemens Medical Solutions | 2022 | — |
| 0 (this device) | K221281 | Multitom Rax | Siemens Medical Solutions | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1994 | 1 | 0 |
| 2005 | 2 | 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 OWB? 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 OWB device
- #1 K251602 Alphenix, INFX-8000V/B, INFX-8000V/S, V9.6…score 18.2 · 18 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 |
|---|---|---|---|
| * | K212212 | Multitom Rax with True2scale Body Scan OptionSummary page 5…vice: Trade Name Multitom Rax With True2scale Body Scan Option Company Siemens Medical Solutions USA, Inc. 510(k) Number K212212 Device Classi- Interventional Fluoroscopic X-ray System ficationName Regulation 892.1650… | 2022 |
| † | K180727 | LineUp | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 2, 2024 | Class II | Z-2528-2024 | Under Investigation by firm | The support arm may unintentionally lower resulting in injury to persons when they are under the display ceiling/wall suspension when positioning the displays |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 36 years and passes through 8 companies; a new generation was cleared every 2.9 years on median.
- 8 of the 14 ancestors have a recall of any class.
How does its category compare?
All OWB devicesOWB Interventional Fluoroscopic X-Ray System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · OWB
22in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWB
148in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWB
42so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWB
14,008in 2025
MAUDE reports naming product code OWB, 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 | 3 | 52 | 0 | 1 |
| 2008 | 4 | 135 | 1 | 0 |
| 2009 | 9 | 99 | 0 | 0 |
| 2010 | 7 | 66 | 0 | 0 |
| 2011 | 6 | 79 | 0 | 1 |
| 2012 | 6 | 37 | 0 | 1 |
| 2013 | 11 | 119 | 10 | 27 |
| 2014 | 15 | 158 | 9 | 103 |
| 2015 | 11 | 66 | 35 | 2,134 |
| 2016 | 16 | 103 | 13 | 4,074 |
| 2017 | 20 | 76 | 13 | 1,604 |
| 2018 | 23 | 54 | 6 | 1,449 |
| 2019 | 9 | 174 | 7 | 1,558 |
| 2020 | 16 | 53 | 8 | 1,581 |
| 2021 | 24 | 60 | 31 | 1,981 |
| 2022 | 21 | 90 | 24 | 2,932 |
| 2023 | 12 | 152 | 22 | 7,604 |
| 2024 | 13 | 126 | 11 | 7,942 |
| 2025 | 22 | 148 | 30 | 14,008 |
| 2026 | 15 | 221 | 42 | — |
What is it indicated for?
Multitom Rax is a device intended to visualize anatomical structures by converting an X- ray pattern into a visible image. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. The unit may also be used in emergency applications, lymphography, endoscopy, myelography, venography, arthrography, interventional radiology, digital…
Read the full statement (210 words)
Multitom Rax is a device intended to visualize anatomical structures by converting an X- ray pattern into a visible image.
The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examinations of the urogenital tract. The unit may also be used in emergency applications, lymphography, endoscopy, myelography, venography, arthrography, interventional radiology, digital angiography, and digital subtraction angiography (DSA). The system may be used on pediatric, adult, and bariatric patients.
The True2scale Body Scan functionality (i.e., slot-scanning-based acquisition and reconstruction technique) of the Multitom Rax is intended to be used for the generation of a geometrically accurate (in scanning direction) 2-D representation of the spine, the lower limbs or the full body which may be used for the assessment of body axes and skeletal alignment. The True2scale Body Scan is not intended to be used for interventional purposes.
The Real3D functionality (i.e., cone-beam CT acquisition and reconstruction technique) of the Multitom Rax is intended to be used for 3-D bone imaging of the head, the upper and lower extremities as well as the lumbar spine.
Real3D is not intended for imaging of the torso of patients with a Body Mass Index (BMI) exceeding 30 kg/m.
Multitom Rax is not for mammography examinations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K221281 · printed Nov 6, 2026
Cite this page
510(k) Report. “K221281: Multitom Rax.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K221281
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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