510(k) · Cleared
ClearedD²RS and D²RS 9090
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stephanix · OWB Interventional Fluoroscopic X-Ray System
Cleared on Dec 23, 2021 as substantially equivalent to K102529 (Stephanix Radiological Systems, 2010) after a 55-day review. Its family tree reaches back 12 generations to 1989. 1 later device descends from it.
- Decided
- Dec 23, 2021
- Review
- 55 days
- Class
- Class II
- Product code
- OWB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K890348 (1989). 84 ancestors in all, the oldest K801623 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 8 generations between
- 3 generations backK092439 Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RFVirtual Imaging, Inc. · 2009
- 2 generations backK093688 Canon, Model Urs-50RFVirtual Imaging, Inc. · 2010
- 1 generation backK102529 D2RF Digital Dynamic Remote SystemStephanix Radiological Systems · 2010 · Recalled
- This deviceK213479 D²RS and D²RS 9090Stephanix · 2021
- Descendant · cites it directly · 0 of its ownK221335 D²RS and D²RS 9090Stephanix · 2022
Show all 12 generations
- Root · 12 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 11 generations backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
- 10 generations backK022322 Innova and Innova 2000 SGe Medical Systems, Inc. · 2002 · Recalled
- 9 generations backK031637 Innova 3100GE Medical Systems · 2003 · Recalled
- 8 generations backK050489 Innova 2100Ge Medical Systems, LLC · 2005 · Recalled
- 7 generations backK052412 Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova…GE Healthcare · 2005 · Recalled
- 6 generations backK060259 Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121Ge Medical Systems, LLC · 2006 · Recalled
- 5 generations backK061163 Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova…Ge Medical Systems, LLC · 2006 · Recalled
- 4 generations backK091658 GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Models…GE Healthcare · 2009 · Recalled
- 3 generations backK092439 Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RFVirtual Imaging, Inc. · 2009
- 2 generations backK093688 Canon, Model Urs-50RFVirtual Imaging, Inc. · 2010
- 1 generation backK102529 D2RF Digital Dynamic Remote SystemStephanix Radiological Systems · 2010 · Recalled
- This deviceK213479 D²RS and D²RS 9090Stephanix · 2021
Most influential descendants
Showing 1 of 1 · See all- K221335D²RS and D²RS 9090Stephanix · 2022 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K890348 | LC, Cardiac Positioner #B5078A | General Electric Co. | 1989 | 5 |
| −11 | K993037 | LCV+ Version 2 | Ge Medical Systems, Inc. | 2000 | 6 |
| −10 | K022322 | Innova and Innova 2000 S | Ge Medical Systems, Inc. | 2002 | 7 |
| −9 | K031637 | Innova 3100 | GE Medical Systems | 2003 | 25 |
| −8 | K050489 | Innova 2100 | Ge Medical Systems, LLC | 2005 | 27 |
| −7 | K052412 | Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQ | GE Healthcare | 2005 | 50 |
| −6 | K060259 | Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121 | Ge Medical Systems, LLC | 2006 | 4 |
| −5 | K061163 | Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova 3100, Innova… | Ge Medical Systems, LLC | 2006 | 38 |
| −4 | K091658 | GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Models Innova… | GE Healthcare | 2009 | 1 |
| −3 | K092439 | Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RF | Virtual Imaging, Inc. | 2009 | — |
| −2 | K093688 | Canon, Model Urs-50RF | Virtual Imaging, Inc. | 2010 | — |
| −1 | K102529 | D2RF Digital Dynamic Remote System | Stephanix Radiological Systems | 2010 | 1 |
| 0 (this device) | K213479 | D²RS and D²RS 9090 | Stephanix | 2021 | — |
| +1 | K221335 | D²RS and D²RS 9090 | Stephanix | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 3 | 0 |
| 1994 | 1 | 0 |
| 1995 | 14 | 0 |
| 1996 | 5 | 0 |
| 1997 | 4 | 0 |
| 1998 | 5 | 0 |
| 1999 | 4 | 0 |
| 2000 | 4 | 0 |
| 2001 | 2 | 0 |
| 2002 | 7 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2006 | 4 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 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 18.3 · 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 |
|---|---|---|---|
| * | K102529 | D2RF Digital Dynamic Remote SystemSummary page 4…Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB,, JAA, IZI 2. Identification of Predicate Device: K102529 Manufacturer: Stephanix Radiological Systems Trade/Device Name: D2RF Digital Dynamic Remote System Regulation N… | 2010 |
| † | K092439 | Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RF | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K221335 | D²RS and D²RS 9090 | 2022 | 0 |
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 32 years and passes through 8 companies; a new generation was cleared every 10 months on median.
- 31 of the 84 ancestors have a recall of any class.
- Of its descendants, K221335 (Stephanix, 2022) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K102529.
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. 2021, 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?
D2RS & D2RS9090 Digital Dynamic Remote System is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic, and interventional procedures. It is also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology. Not intended for mammography applications.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K213479 · printed Nov 5, 2026
Cite this page
510(k) Report. “K213479: D²RS and D²RS 9090.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K213479
Report an extraction error
Are you the manufacturer?
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