510(k) · Cleared
ClearedSiregragh T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic X-Ray Systems
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 Apr 21, 1997 as substantially equivalent to K860913 (Siemens Medical Solutions USA, Inc., 1986) and 1 other predicate after a 52-day review. Its family tree reaches back 2 generations to 1991. 131 later devices descend from it.
- Decided
- Apr 21, 1997
- Review
- 52 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K912470 (1991). 5 ancestors in all, the oldest K860913 (1986). 131 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK912470 Philips Diagnost 96Philips Medical Systems, Inc. · 1991 · Recalled
- 1 generation backK960266 Siregraph CFSiemens Medical Solutions USA, Inc. · 1996 · Recalled
- This deviceK970734 Siregragh T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic…Siemens Medical Solutions USA, Inc. · 1997
- Descendant · cites it directly · 130 of its ownK992660 Urf Digital - OTSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- Descendant · 2 generations on · 78 of its ownK062623 Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · Recalled
- Descendant · 2 generations on · 49 of its ownK040675 Axiom Artis USiemens Medical Systems, Inc. · 2004 · Recalled
- Descendant · 3 generations on · 43 of its ownK081722 YSIOSiemens Medical Solutions USA, Inc. · 2008 · Recalled
- Descendant · 4 generations on · 32 of its ownK121513 Multix FusionSiemens Medical Solution · 2012 · Recalled
Showing 5 of 131 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 131 · See all- K992660Urf Digital - OTSiemens Medical Solutions USA, Inc. · 1999 · cites it directly130descendants
- K062623Axiom Luminos DRFSiemens Medical Solutions USA, Inc. · 2007 · 2 generations on78descendants
- K040675Axiom Artis USiemens Medical Systems, Inc. · 2004 · 2 generations on49descendants
- K081722YSIOSiemens Medical Solutions USA, Inc. · 2008 · 3 generations on43descendants
- K121513Multix FusionSiemens Medical Solution · 2012 · 4 generations on32descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K912470 | Philips Diagnost 96 | Philips Medical Systems, Inc. | 1991 | 9 |
| −1 | K960266 | Siregraph CF | Siemens Medical Solutions USA, Inc. | 1996 | 3 |
| 0 (this device) | K970734 | Siregragh T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic X-Ray Systems | Siemens Medical Solutions USA, Inc. | 1997 | — |
| +1 | K992660 | Urf Digital - OT | Siemens Medical Solutions USA, Inc. | 1999 | 4 |
| +2 | K062623 | Axiom Luminos DRF | Siemens Medical Solutions USA, Inc. | 2007 | 20 |
| +2 | K040675 | Axiom Artis U | Siemens Medical Systems, Inc. | 2004 | 1 |
| +3 | K081722 | YSIO | Siemens Medical Solutions USA, Inc. | 2008 | 11 |
| +4 | K121513 | Multix Fusion | Siemens Medical Solution | 2012 | 4 |
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 |
|---|---|---|
| 1999 | 1 | 0 |
| 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? (2)
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 |
|---|---|---|---|
| * | K860913 | Siregraph DSummary page 2…es in commercial distribution: Simplified 510(k) for Siregraph T.O.P. 33 & 20 Siemens Medical Systems, Inc. Pg. 57 of 58 SIEMENS Siregraph D3 and D340, K860913 Siemens Medical Systems, Inc. o Siregraph CF, K960266 Siemens Medical Systems, Inc. 5. Device Description: Siregraph TO.P. is a… | 1986 |
| * | K960266 | Siregraph CFSummary page 2…iregraph T.O.P. 33 & 20 Siemens Medical Systems, Inc. Pg. 57 of 58 SIEMENS Siregraph D3 and D340, K860913 Siemens Medical Systems, Inc. o Siregraph CF, K960266 Siemens Medical Systems, Inc. 5. Device Description: Siregraph TO.P. is a universal fluoroscopic X-ray diagnostic system with an… | 1996 |
What descends from it? (131)
See all 1311 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992660 | Urf Digital - OT | 1999 | 130 |
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 6 years and passes through 2 companies; a new generation was cleared every 4.6 years on median.
- 4 of the 5 ancestors have a recall of any class.
- Of its descendants, K992660 (Siemens Medical Solutions USA, Inc., 1999) has gone furthest, with 130 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 Siregraph T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic X-ray Systems are devices intended to visualize anatomical structures by converting a pattern of X-ray into a visible image through electronic amplification. Both systems have medical applications ranging from gastrointestinal examinations to cranial, skeletal, thoracic and lung exposures as well as examination of the urogenital tract, 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/K970734 · printed Nov 6, 2026
Cite this page
510(k) Report. “K970734: Siregragh T.O.P. 33 and Siregraph T.O.P. 40 Universal Fluoroscopic X-Ray Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K970734
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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