510(k) · Cleared
ClearedD2RS_AT Digital Dynamic Remote System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stephanix Radiological Solutions · JAA System, X-Ray, Fluoroscopic, Image-Intensified
Cleared on Oct 10, 2015 as substantially equivalent to K102529 (Stephanix Radiological Systems, 2010) after a 243-day review. Its family tree reaches back 12 generations to 1989.
- Decided
- Oct 10, 2015
- Review
- 243 days
- Class
- Class II
- Product code
- JAA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K890348 (1989). 84 ancestors in all, the oldest K801623 (1980). No later device cites it as a predicate yet.
- 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 deviceK150306 D2RS_AT Digital Dynamic Remote SystemStephanix Radiological Solutions · 2015
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 deviceK150306 D2RS_AT Digital Dynamic Remote SystemStephanix Radiological Solutions · 2015
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) | 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 |
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 JAA? 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 JAA device
- #1 K253103 Nexus DRF Digital X-ray Imaging Systemscore 13.2 · 7 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 Identification of Predicate Stephanix D2RF Digital Dynamic Remote System, K102529 Device, Classification 21 CFR § 892.1650, System, x-ray, fluoroscopic, image-intensified regulation, classification… | 2010 |
| † | K131314 | Ddrcruze (Digital Mobile Diagnostic X-Ray System) | 2013 |
| † | K141440 | Dicompacs DX-R with Flat Panel | 2014 |
| † | K142718 | Radlink GPS | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 26 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.
- 1 other device also cites its predicate K102529.
How does its category compare?
All JAA devicesJAA System, X-Ray, Fluoroscopic, Image-Intensified: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · JAA
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JAA
89in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JAA
4in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JAA
33in 2025
MAUDE reports naming product code JAA, 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 | 1 | — | 35 | 9,517 |
| 2008 | 6 | 18 | 21 | 9,484 |
| 2009 | 0 | — | 18 | 12,040 |
| 2010 | 1 | — | 6 | 5,803 |
| 2011 | 4 | 48 | 7 | 14,000 |
| 2012 | 1 | — | 2 | 11,684 |
| 2013 | 6 | 129 | 3 | 13,706 |
| 2014 | 6 | 276 | 1 | 10,265 |
| 2015 | 3 | 197 | 1 | 2,922 |
| 2016 | 2 | — | 7 | 35 |
| 2017 | 1 | — | 3 | 56 |
| 2018 | 3 | 30 | 1 | 36 |
| 2019 | 6 | 49 | 2 | 49 |
| 2020 | 4 | 39 | 2 | 39 |
| 2021 | 6 | 104 | 2 | 35 |
| 2022 | 1 | — | 5 | 34 |
| 2023 | 2 | — | 9 | 41 |
| 2024 | 3 | 89 | 2 | 25 |
| 2025 | 2 | — | 4 | 33 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The D’RS_AT Digital Dynamic Remote System Is indicated for use in generating fluoroscopic images of human anatomy for diagnostic procedures. It Is intended to replace fluoroscopic 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/K150306 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150306: D2RS_AT 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/K150306
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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