510(k) · Cleared
Recalled · Class II · 2022Axiom Luminos DRF
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Siemens Medical Solutions USA, Inc. · OWB Interventional Fluoroscopic X-Ray System
Cleared on Aug 22, 2007 as substantially equivalent to K992660 (Siemens Medical Solutions USA, Inc., 1999) and 2 other predicates after a 351-day review. Its family tree reaches back 7 generations to 1980. 78 later devices descend from it. It has been recalled 20 times.
- Decided
- Aug 22, 2007
- Review
- 351 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 20
- Predicates
- 3
Its longest line of descent runs back 7 generations to K801623 (1980). 55 ancestors in all. 78 later devices descend from it, 10 citing it directly.
- Root · 7 generations backK801623 Cavitron Ultrasonic Surg. Aspir. CusaCavitron Corp. · 1980
- 6 generations backK962952 Olympus Ultrasonic Surgical System (Usu)Olympus Optical, Co. · 1996
- 5 generations backK972114 Olympus Sonosurg SystemThe Olympus Optical Co. · 1998
- 4 generations backK981993 Olympus Integrated Endosurgery System EndoalphaThe Olympus Optical Co. · 1998
- 3 generations backK994231 Siemens Integrated Operating System (Sios)Siemens Medical Corp. · 2000
- 2 generations backK052202 Axiom Artis - Modular Angiographic SystemSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- 1 generation backK061054 Axiom Aristos FX PlusSiemens Medical Solutions USA, Inc. · 2006 · Recalled
- This deviceK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007
- 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
- Descendant · cites it directly · 11 of its ownK101491 Uroskop OmniaSiemens Medical Solutions USA, Inc. · 2010 · Recalled
Showing 5 of 78 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 78 · See all- 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
- K101491Uroskop OmniaSiemens Medical Solutions USA, Inc. · 2010 · cites it directly11descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K801623 | Cavitron Ultrasonic Surg. Aspir. Cusa | Cavitron Corp. | 1980 | — |
| −6 | K962952 | Olympus Ultrasonic Surgical System (Usu) | Olympus Optical, Co. | 1996 | — |
| −5 | K972114 | Olympus Sonosurg System | The Olympus Optical Co. | 1998 | — |
| −4 | K981993 | Olympus Integrated Endosurgery System Endoalpha | The Olympus Optical Co. | 1998 | — |
| −3 | K994231 | Siemens Integrated Operating System (Sios) | Siemens Medical Corp. | 2000 | — |
| −2 | K052202 | Axiom Artis - Modular Angiographic System | Siemens Medical Solutions USA, Inc. | 2006 | 29 |
| −1 | K061054 | Axiom Aristos FX Plus | Siemens Medical Solutions USA, Inc. | 2006 | 3 |
| 0 (this device) | K062623 | Axiom Luminos DRF | Siemens Medical Solutions USA, Inc. | 2007 | — |
| +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 | — |
| +1 | K101491 | Uroskop Omnia | Siemens Medical Solutions USA, Inc. | 2010 | 12 |
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 | 1 | 0 |
| 1995 | 12 | 0 |
| 1996 | 4 | 0 |
| 1997 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 3 | 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 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 18.3 · 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? (3)
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 |
|---|---|---|---|
| * | K992660 | Urf Digital - OTSummary page 2…tially equivalent to the commercially available Siemens system, the URF Digital OT. The URF Digital OT, marketed as AXIOM Iconos was described in premarket notification K992660 which received FDA Clearance on November 5, 1999. The Flat Detector Pixium 5100 equipped with AXIOM Luminos dRF is an improved d… | 1999 |
| * | K061054 | Axiom Aristos FX PlusSummary page 2…FX Plus and substantial equivalent to the Pixium 4800 used with AXIOM Artis modular Angiography system. The AXIOM Aristos FX Plus was described in premarket notification K061054 which received FDA Clearance on May 09, 2006. The AXIOM Artis Modular Angiography system was described in premarket notification… | 2006 |
| * | K021021 | Modular Angiography System Axiom ArtisSummary page 2…ribed in premarket notification K061054 which received FDA Clearance on May 09, 2006. The AXIOM Artis Modular Angiography system was described in premarket notification K021021 which received FDA Clearance on June 06, 2002. 5. Device Description AXIOM Luminos dRF is a universal fluoroscopic x-ray diagnos… | 2002 |
What descends from it? (78)
See all 7810 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081722 | YSIO | 2008 | 43 |
| K101491 | Uroskop Omnia | 2010 | 11 |
| K092439 | Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RF | 2009 | 10 |
| K093688 | Canon, Model Urs-50RF | 2010 | 5 |
| K152928 | Multitom Rax | 2015 | 3 |
| K131766 | Platinum DRF Imaging System | 2013 | 2 |
| K111292 | Luminos Agile | 2011 | 2 |
| K080859 | DRF 4343 | 2008 | 2 |
| K173639 | Luminos dRF Max, Luminos Agile Max, Uroskop Omnia Max, Multitom Rax | 2018 | 1 |
| K081073 | HDR Vision, Vision HDR, HD R/F, Uromat HD R/F | 2008 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 21, 2022 | Class II | Z-1166-2023 | Software design | Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values |
| Dec 21, 2022 | Class II | Z-1164-2023 | Software design | Potential risk of collision with the ceiling, wall, or objects which may result in serious injury to staff or patients due to room configuration parameters of the system being set to default values |
| Apr 13, 2015 | Class II | Z-1668-2015 | Software design | Study and all acquired images deleted when using systems with software version VE10E. Acquisitions have to be repeated. Connection with portable detectors (MAX wi-D, MAX mini) is sporadic in image recovery. Pressing undo button on the RAD… |
| Dec 15, 2014 | Class II | Z-0994-2015 | Software design | Potential for composed images to be flipped before being sent to PACS on systems with software version VE10 and SmartOrtho license. Flipped images may be reversed so the associated annotations, e.g. labels (R/L), may be displayed… |
| Sep 2, 2014 | Class II | Z-0003-2015 | Software design | Two malfunctions posing potential risk to patients were identified with Siemens Ysio Max, AXIOM Luminos dRF Max, Uroskop Omnia Max, and Luminos Agile Max systems with a specific set of serial numbers that will cause lost images due to an… |
| Aug 12, 2014 | Class II | Z-2649-2014 | Equipment maintenance | It was determined that a potential malfunction may occur on the Luminos dRF system with SW VD10 or on Luminos dRF Max when the table side control is exposed to fluids. Fluid may infiltrate the tableside control panel and result in… |
| 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… |
| Apr 11, 2014 | Class II | Z-1711-2014 | Device Design | It was determined that under rare environmental conditions (i.e., extremely dry air in combination with a highly isolated floor) electrostatic discharges (ESD) >8 kV may trigger an unintended movement of the AXIOM Luminos dRFsystem which… |
| Sep 3, 2013 | Class II | Z-0140-2014 | Software design | When using systems operating with software versions VD10A/G during a RAD examination, a malfunction can result in radiation continuing longer than required resulting in an overexposed image that is not of diagnostic quality, prompting… |
| 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 7, 2013 | Class II | Z-1848-2013 | Software design | Siemens became aware of an unintended behavior when using the Luminos dRF with software version VD10A. The possibility exists that a software error may occur causing the table to tilt into an upright position and may collide with the… |
| 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 16, 2012 | Not classified | Z-1383-2012 | Nonconforming Material/Component | During regular product monitoring, Siemens became aware of a potential issue with the AXIOM Luminos dRF. Firm became aware of a potential issue with torque wrenches - during a regular scheduled calibration of the wrench, it was discovered… |
| 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… |
| Jan 14, 2011 | Not classified | Z-1421-2011 | Other | Firm became aware of a potential malfunction and possible hazard to patients in the event the tilt buttons on the OPTI Grip become stuck under the housing |
| Oct 25, 2010 | Not classified | Z-0717-2011 | Other | patient leg can be pinched |
| Jul 13, 2010 | Not classified | Z-2222-2010 | Device Design | Fluid may enter the multi-functional handle (Opti Grip) when using the Axiom Luminos TF or Sireskop SD system, causing unintended reaction or movement, increased radiation or useless images. |
| Sep 19, 2008 | Not classified | Z-0327-2009 | Nonconforming Material/Component | Issue may occur where an intended movement of the joystick may unintentionally initiate an x-ray exposure. |
| Sep 19, 2008 | Not classified | Z-0326-2009 | Nonconforming Material/Component | Issue may occur where an intended movement of the joystick may unintentionally initiate an x-ray exposure. |
The 5 latest of 20 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 27 years and passes through 5 companies; a new generation was cleared every 1.5 years on median.
- 17 of the 55 ancestors have a recall of any class.
- Of its descendants, K081722 (Siemens Medical Solutions USA, Inc., 2008) has gone furthest, with 43 descendants of its own.
- 2 other devices also cite its predicate K992660.
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. 2007, 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?
The AXTOM Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations. The AXIOM Iconos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. The system has medical applications ranging from but not limited…
Read the full statement (131 words)
The AXTOM Luminos dRF is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic studies. Using a digital flat detector, it can perform a range of applications including general R/F, angiography and pediatric examinations.
The AXIOM Iconos dRF is a device intended to visualize anatomical structures by converting a pattern of X-ray into a visible image. The system has medical applications ranging from but not limited to gastrointestinal examinations, cranial, skeletal, thoracic and lung exposures as well as examination of the urogenital tract. The units may also be used in lymphography, endoscopy, myelography, venography, pediatrics, arthrography, interventional radiology, digital angiography and digital subtraction angiography (DSA).
AXIOM Luminos dRF may be used for outpatient and emergency treatment, as well as for mobile transport (wheelchair and bed) examinations.
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/K062623 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062623: Axiom Luminos DRF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062623
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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