510(k) · Cleared
Recalled · Class II · 2018D2RF Digital Dynamic Remote System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stephanix Radiological Systems · OWB Interventional Fluoroscopic X-Ray System
Cleared on Oct 7, 2010 as substantially equivalent to K093688 (Virtual Imaging, Inc., 2010) after a 35-day review. Its family tree reaches back 11 generations to 1989. 3 later devices descend from it. It has been recalled once.
- Decided
- Oct 7, 2010
- Review
- 35 days
- Class
- Class II
- Product code
- OWB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 11 generations to K890348 (1989). 83 ancestors in all, the oldest K801623 (1980). 3 later devices descend from it, 2 citing it directly.
- Root · 11 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 7 generations between
- 3 generations backK091658 GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Models…GE Healthcare · 2009 · Recalled
- 2 generations backK092439 Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RFVirtual Imaging, Inc. · 2009
- 1 generation backK093688 Canon, Model Urs-50RFVirtual Imaging, Inc. · 2010
- This deviceK102529 D2RF Digital Dynamic Remote SystemStephanix Radiological Systems · 2010
- Descendant · cites it directly · 1 of its ownK213479 D²RS and D²RS 9090Stephanix · 2021
- Descendant · 2 generations on · 0 of its ownK221335 D²RS and D²RS 9090Stephanix · 2022
- Descendant · cites it directly · 0 of its ownK150306 D2RS_AT Digital Dynamic Remote SystemStephanix Radiological Solutions · 2015
Show all 11 generations
- Root · 11 generations backK890348 LC, Cardiac Positioner #B5078AGeneral Electric Co. · 1989 · Recalled
- 10 generations backK993037 LCV+ Version 2Ge Medical Systems, Inc. · 2000 · Recalled
- 9 generations backK022322 Innova and Innova 2000 SGe Medical Systems, Inc. · 2002 · Recalled
- 8 generations backK031637 Innova 3100GE Medical Systems · 2003 · Recalled
- 7 generations backK050489 Innova 2100Ge Medical Systems, LLC · 2005 · Recalled
- 6 generations backK052412 Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova…GE Healthcare · 2005 · Recalled
- 5 generations backK060259 Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121Ge Medical Systems, LLC · 2006 · Recalled
- 4 generations backK061163 Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova…Ge Medical Systems, LLC · 2006 · Recalled
- 3 generations backK091658 GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Models…GE Healthcare · 2009 · Recalled
- 2 generations backK092439 Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RFVirtual Imaging, Inc. · 2009
- 1 generation backK093688 Canon, Model Urs-50RFVirtual Imaging, Inc. · 2010
- This deviceK102529 D2RF Digital Dynamic Remote SystemStephanix Radiological Systems · 2010
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K890348 | LC, Cardiac Positioner #B5078A | General Electric Co. | 1989 | 5 |
| −10 | K993037 | LCV+ Version 2 | Ge Medical Systems, Inc. | 2000 | 6 |
| −9 | K022322 | Innova and Innova 2000 S | Ge Medical Systems, Inc. | 2002 | 7 |
| −8 | K031637 | Innova 3100 | GE Medical Systems | 2003 | 25 |
| −7 | K050489 | Innova 2100 | Ge Medical Systems, LLC | 2005 | 27 |
| −6 | K052412 | Innova 2100-IQ, Innova 3100, Innova 3100-IQ, Innova 4100, and Innova 4100-IQ | GE Healthcare | 2005 | 50 |
| −5 | K060259 | Digital Fluoroscopic Imaging Systems - Innova 3131 & Innova 2121 | Ge Medical Systems, LLC | 2006 | 4 |
| −4 | K061163 | Innova 2121IQ, Innova 3131IQ, Innova 4100, Innova 4100IQ, Innova 3100, Innova… | Ge Medical Systems, LLC | 2006 | 38 |
| −3 | K091658 | GE Innova Solid State Xray-Imager Fluoroscopic X-Ray System, Models Innova… | GE Healthcare | 2009 | 1 |
| −2 | K092439 | Canon Digital Fluoroscopy and Radiography, Model Cxdi-50RF | Virtual Imaging, Inc. | 2009 | — |
| −1 | K093688 | Canon, Model Urs-50RF | Virtual Imaging, Inc. | 2010 | — |
| 0 (this device) | K102529 | D2RF Digital Dynamic Remote System | Stephanix Radiological Systems | 2010 | — |
| +1 | K213479 | D²RS and D²RS 9090 | Stephanix | 2021 | — |
| +2 | K221335 | D²RS and D²RS 9090 | Stephanix | 2022 | — |
| +1 | K150306 | D2RS_AT Digital Dynamic Remote System | Stephanix Radiological Solutions | 2015 | — |
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 |
|---|---|---|
| 2015 | 1 | 0 |
| 2021 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K093688 | Canon, Model Urs-50RFSummary page 1…Code: . 0 JRA y 121 Regulation: 21 CFR § 892.1650 ? Identification of Canon Dynamic/Static DR Madel URS-SORF Fluoroscopic Digital Predicate Devices and X-Ray System X(093688, Virtual Imaging Summary of Substantial . Equivalence Device Description D’RS is a direct digital dynamic remote-controlled fl… | 2010 |
| * | — | Virtual Imaging Named without a submission number |
What descends from it? (3)
2 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 |
|---|---|---|---|---|
| Nov 2, 2018 | Class II | Z-0557-2019 | Software design | The firm has detected a potential risk using the command. After releasing the command, the movement of the table may continue instead of stopping. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 7 companies; a new generation was cleared every 8 months on median.
- 30 of the 83 ancestors have a recall of any class.
- Of its descendants, K213479 (Stephanix, 2021) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K093688.
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. 2010, 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 D'RF 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, diagnastic, and interventional procedures. 1t is Intended to replace fluoroscepic images obtained through image intensifier technology. Not intended for mammography applications.
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/K102529 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102529: D2RF Digital Dynamic Remote System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102529
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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