510(k) · Cleared
Recalled · Class II · 2014Wireless DR Imaging Option-WDR1
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ge Medical Systems, LLC · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Nov 18, 2010 as substantially equivalent to K982196 (GE Medical Systems, 1998) and 1 other predicate after a 70-day review. Its family tree reaches back 3 generations to 1994. 6 later devices descend from it. It has been recalled once.
- Decided
- Nov 18, 2010
- Review
- 70 days
- Class
- Class II
- Product code
- MQB
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 3 generations to K931071 (1994). 7 ancestors in all, the oldest K862120 (1986). 6 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK931071 Philips ThoravisionPhilips Medical Systems, Inc. · 1994 · Recalled
- 2 generations backK982795 Philips Bucky VisionPhilips Medical Systems, Inc. · 1998 · Recalled
- 1 generation backK090625 Wireless Portable Detector FD-W17Philips Medical Systems North America Co. · 2009 · Recalled
- This deviceK102615 Wireless DR Imaging Option-WDR1Ge Medical Systems, LLC · 2010
- Descendant · cites it directly · 5 of its ownK103476 BRIVOXR285AMX, Optima XR200AMX, OPTIMAXR220AMXGe Medical Systems, LLC · 2011 · Recalled
- Descendant · 2 generations on · 4 of its ownK142383 Optima XR200amx, Optima XR220amxGe Medical Systems, LLC · 2014 · Recalled
- Descendant · 3 generations on · 3 of its ownK162990 Optima XR240amxGe Medical Systems, LLC · 2016 · Recalled
- Descendant · 4 generations on · 2 of its ownK173602 Optima XR240amx, AutoGridGe Medical Systems, LLC · 2018 · Recalled
- Descendant · 5 generations on · 1 of its ownK182234 Optima XR240amxGe Medical Systems, LLC · 2018 · Recalled
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K103476BRIVOXR285AMX, Optima XR200AMX, OPTIMAXR220AMXGe Medical Systems, LLC · 2011 · cites it directly5descendants
- K142383Optima XR200amx, Optima XR220amxGe Medical Systems, LLC · 2014 · 2 generations on4descendants
- K162990Optima XR240amxGe Medical Systems, LLC · 2016 · 3 generations on3descendants
- K173602Optima XR240amx, AutoGridGe Medical Systems, LLC · 2018 · 4 generations on2descendants
- K182234Optima XR240amxGe Medical Systems, LLC · 2018 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K931071 | Philips Thoravision | Philips Medical Systems, Inc. | 1994 | 1 |
| −2 | K982795 | Philips Bucky Vision | Philips Medical Systems, Inc. | 1998 | 17 |
| −1 | K090625 | Wireless Portable Detector FD-W17 | Philips Medical Systems North America Co. | 2009 | 28 |
| 0 (this device) | K102615 | Wireless DR Imaging Option-WDR1 | Ge Medical Systems, LLC | 2010 | — |
| +1 | K103476 | BRIVOXR285AMX, Optima XR200AMX, OPTIMAXR220AMX | Ge Medical Systems, LLC | 2011 | 8 |
| +2 | K142383 | Optima XR200amx, Optima XR220amx | Ge Medical Systems, LLC | 2014 | 8 |
| +3 | K162990 | Optima XR240amx | Ge Medical Systems, LLC | 2016 | 2 |
| +4 | K173602 | Optima XR240amx, AutoGrid | Ge Medical Systems, LLC | 2018 | 2 |
| +5 | K182234 | Optima XR240amx | Ge Medical Systems, LLC | 2018 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2018 | 2 | 0 |
| 2021 | 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 MQB? 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 MQB device
- #1 K201528 Yushan X-Ray Flat Panel Detector with DROCscore 21.5 · 12 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 |
|---|---|---|---|
| * | K982196 | Digital Radiographic Imaging SystemSummary page 1…al, tethered cable or direct connection (docked). The Wireless detector is very similar to the digital detector currently in use as the GE Digital Radiographic Detector (K982196), and the Philips 5-2 KIOZG (S P LD GE Medical Systems, LLC 510(k) Premarket Notification Wireless DR Imaging O… | 1998 |
| * | K090625 | Wireless Portable Detector FD-W17Summary page 2…KIOZG (S P LD GE Medical Systems, LLC 510(k) Premarket Notification Wireless DR Imaging Option WDRI Medical Systems Wireless Portable Detector FD-W17 (K090625) comprised of amorphous silicon with a cesium iodide scintillator. It is used on radiographic X-ray systems as a substitute for… | 2009 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K103476 | BRIVOXR285AMX, Optima XR200AMX, OPTIMAXR220AMX | 2011 | 5 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 20, 2014 | Class II | Z-1078-2014 | Software design | GE Healthcare has recently become aware of a software issue associated with patient selection from the worklist on your WDR1(Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography Option) that may impact patient… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- 5 of the 7 ancestors have a recall of any class.
- Of its descendants, K103476 (Ge Medical Systems, LLC, 2011) has gone furthest, with 5 descendants of its own.
- 3 other devices also cite its predicate K982196.
How does its category compare?
All MQB devicesMQB Solid State X-Ray Imager (Flat Panel/Digital Imager): FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · MQB
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MQB
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MQB
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MQB
141in 2025
MAUDE reports naming product code MQB, 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 | 13 | 22 | 15 | 25 |
| 2008 | 8 | 15 | 36 | 30 |
| 2009 | 15 | 57 | 19 | 34 |
| 2010 | 11 | 116 | 14 | 39 |
| 2011 | 24 | 102 | 10 | 101 |
| 2012 | 22 | 80 | 8 | 267 |
| 2013 | 21 | 105 | 6 | 159 |
| 2014 | 32 | 102 | 0 | 29 |
| 2015 | 21 | 81 | 0 | 21 |
| 2016 | 22 | 92 | 0 | 26 |
| 2017 | 31 | 30 | 1 | 20 |
| 2018 | 16 | 30 | 4 | 84 |
| 2019 | 22 | 30 | 1 | 45 |
| 2020 | 19 | 28 | 4 | 9 |
| 2021 | 21 | 48 | 1 | 26 |
| 2022 | 31 | 48 | 0 | 13 |
| 2023 | 10 | 30 | 0 | 51 |
| 2024 | 8 | 187 | 0 | 91 |
| 2025 | 8 | 127 | 1 | 141 |
| 2026 | 3 | 245 | 1 | — |
What is it indicated for?
The Wireless DR Imaging Option -WDRI, when used with a radiographic imaging system, is indicated for use in generating radiographic images of human anatomy. It is intended for use in all routine radiography exams, and specialized areas including pediatric work, intensive care and trauma, wherever conventional screen-film systems or CR systems maybe used.
The device is not intended for mammography or fluoroscopy 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/K102615 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102615: Wireless DR Imaging Option-WDR1.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102615
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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