510(k) · Cleared
Recalled · Class II · 2022Urf Digital - OT
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 Nov 5, 1999 as substantially equivalent to K970734 (Siemens Medical Solutions USA, Inc., 1997) after an 88-day review. Its family tree reaches back 3 generations to 1991. 130 later devices descend from it. It has been recalled 4 times.
- Decided
- Nov 5, 1999
- Review
- 88 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 4
- Predicates
- 1
Its longest line of descent runs back 3 generations to K912470 (1991). 6 ancestors in all, the oldest K860913 (1986). 130 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK912470 Philips Diagnost 96Philips Medical Systems, Inc. · 1991 · Recalled
- 2 generations backK960266 Siregraph CFSiemens Medical Solutions USA, Inc. · 1996 · Recalled
- 1 generation backK970734 Siregragh T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic…Siemens Medical Solutions USA, Inc. · 1997
- This deviceK992660 Urf Digital - OTSiemens Medical Solutions USA, Inc. · 1999
- Descendant · cites it directly · 78 of its ownK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- Descendant · cites it directly · 49 of its ownK040675 Axiom Artis USiemens Medical Systems, Inc. · 2004 · Recalled
- Descendant · 2 generations on · 43 of its ownK081722 YSIOSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- Descendant · 3 generations on · 32 of its ownK121513 Multix FusionSiemens Medical Solution · 2012 · Recalled
- Descendant · 3 generations on · 23 of its ownK133259 Ysio MaxSiemens Medical Solutions USA, Inc. · 2014 · Recalled
Showing 5 of 130 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 130 · See all- K062623Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · cites it directly78descendants
- K040675Axiom Artis USiemens Medical Systems, Inc. · 2004 · cites it directly49descendants
- K081722YSIOSiemens Medical Solutions USA, Inc. · 2008 · 2 generations on43descendants
- K121513Multix FusionSiemens Medical Solution · 2012 · 3 generations on32descendants
- K133259Ysio MaxSiemens Medical Solutions USA, Inc. · 2014 · 3 generations on23descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K912470 | Philips Diagnost 96 | Philips Medical Systems, Inc. | 1991 | 9 |
| −2 | K960266 | Siregraph CF | Siemens Medical Solutions USA, Inc. | 1996 | 3 |
| −1 | K970734 | Siregragh T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic X-Ray Systems | Siemens Medical Solutions USA, Inc. | 1997 | — |
| 0 (this device) | K992660 | Urf Digital - OT | Siemens Medical Solutions USA, Inc. | 1999 | — |
| +1 | K062623 | Axiom Luminos DRF | Siemens Medical Solutions USA, Inc. | 2007 | 20 |
| +1 | K040675 | Axiom Artis U | Siemens Medical Systems, Inc. | 2004 | 1 |
| +2 | K081722 | YSIO | Siemens Medical Solutions USA, Inc. | 2008 | 11 |
| +3 | K121513 | Multix Fusion | Siemens Medical Solution | 2012 | 4 |
| +3 | K133259 | Ysio Max | Siemens Medical Solutions USA, Inc. | 2014 | 7 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 5 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 5 | 0 |
| 2015 | 5 | 0 |
| 2016 | 7 | 0 |
| 2017 | 3 | 0 |
| 2018 | 9 | 0 |
| 2019 | 11 | 0 |
| 2020 | 13 | 0 |
| 2021 | 11 | 0 |
| 2022 | 8 | 0 |
| 2023 | 7 | 0 |
| 2024 | 6 | 0 |
| 2025 | 11 | 0 |
| 2026 | 8 | 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? (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 |
|---|---|---|---|
| * | K970734 | Siregragh T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic X-Ray SystemsSummary page 1…y equivalent to Siemens Siregraph T.O.P. 33 and 40 that are currently in commercial distribution. The Siregraph T.O.P. 33 and 40 were described in premarket notification K970734, which received FDA clearance on April 21, 1997. 510(k) for Siemens URF Digital-OT Page 52 of 54 5. Device Descr… | 1997 |
What descends from it? (130)
See all 1303 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 |
|---|---|---|---|---|
| Dec 9, 2022 | Class II | Z-1000-2023 | Process control | There is potential for the footrest to detach from the patient table during use. |
| Jan 15, 2013 | Class II | Z-1097-2013 | Process design | Siemens has become aware of a potential malfunction and possible hazard to patients and staff when using the Iconos R200 C20, Iconos R200 T20, Iconos R100, Iconos MD, Iconos RHD, Luminos RF Classic, Luminos Fusion or Luminos Select. This… |
| Jan 29, 2010 | Not classified | Z-1213-2010 | Software design | table can tilt/move when it is not intended |
| May 1, 2009 | Not classified | Z-1438-2009 | Other | Improper installation of accessory support arm, which could potentially result in the loosening of the arm over time causing it to fall. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 8 years and passes through 2 companies; a new generation was cleared every 2.5 years on median.
- 4 of the 6 ancestors have a recall of any class.
- Of its descendants, K062623 (Siemens Medical Solutions USA, Inc., 2007) has gone furthest, with 78 descendants of its own.
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.
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 Siemens URF Digital - OT is intended to visualize anatomical structures by converting a pattern of X-ray into a visible image through electronic amplification. The system has medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures, as well as examination of the urogenital tract. The URF Digital - OT may also be used in lymphography, endoscopy, myelography, venography, pediatrics, arthrography, interventional radiology, digital angiography, and digital subtraction angiography (DSA).
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/K992660 · printed Nov 6, 2026
Cite this page
510(k) Report. “K992660: Urf Digital - OT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K992660
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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