510(k) · Cleared
Recalled · Class II · 2018Wireless Portable Detector FD-W17
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems North America Co. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Mar 24, 2009 as substantially equivalent to K982795 (Philips Medical Systems, Inc., 1998) after a 15-day review. Its family tree reaches back 2 generations to 1994. 41 later devices descend from it. It has been recalled 28 times.
- Decided
- Mar 24, 2009
- Review
- 15 days
- Class
- Class II
- Product code
- MQB
- Recalls
- 28
- Predicates
- 1
Its longest line of descent runs back 2 generations to K931071 (1994). 4 ancestors in all. 41 later devices descend from it, 7 citing it directly.
- Root · 2 generations backK931071 Philips ThoravisionPhilips Medical Systems, Inc. · 1994 · Recalled
- 1 generation backK982795 Philips Bucky VisionPhilips Medical Systems, Inc. · 1998 · Recalled
- This deviceK090625 Wireless Portable Detector FD-W17Philips Medical Systems North America Co. · 2009
- Descendant · cites it directly · 14 of its ownK112132 Krystalrad 660 Digital Radiographic Portable Retrofit SystemMedicatech USA · 2011
- Descendant · 2 generations on · 11 of its ownK130883 Sedecal Digital Radiographic Upgrade Model Sdru-TSedecal., Sa. · 2013
- Descendant · 3 generations on · 7 of its ownK140825 Delworks DR SystemDel Medical, Inc. · 2014
- Descendant · 3 generations on · 6 of its ownK162529 DigiX FDXAllengers Medical Systems Limited · 2017
- Descendant · cites it directly · 6 of its ownK141736 Philips Prograde; Philips Eleva Workspot for Digital DiagnostPhilips Medical Systems Dmc GmbH · 2014 · Recalled
Showing 5 of 41 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 41 · See all- K112132Krystalrad 660 Digital Radiographic Portable Retrofit SystemMedicatech USA · 2011 · cites it directly14descendants
- K130883Sedecal Digital Radiographic Upgrade Model Sdru-TSedecal., Sa. · 2013 · 2 generations on11descendants
- K140825Delworks DR SystemDel Medical, Inc. · 2014 · 3 generations on7descendants
- K162529DigiX FDXAllengers Medical Systems Limited · 2017 · 3 generations on6descendants
- K141736Philips Prograde; Philips Eleva Workspot for Digital DiagnostPhilips Medical Systems Dmc GmbH · 2014 · cites it directly6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K931071 | Philips Thoravision | Philips Medical Systems, Inc. | 1994 | 1 |
| −1 | K982795 | Philips Bucky Vision | Philips Medical Systems, Inc. | 1998 | 17 |
| 0 (this device) | K090625 | Wireless Portable Detector FD-W17 | Philips Medical Systems North America Co. | 2009 | — |
| +1 | K112132 | Krystalrad 660 Digital Radiographic Portable Retrofit System | Medicatech USA | 2011 | — |
| +2 | K130883 | Sedecal Digital Radiographic Upgrade Model Sdru-T | Sedecal., Sa. | 2013 | — |
| +3 | K140825 | Delworks DR System | Del Medical, Inc. | 2014 | — |
| +3 | K162529 | DigiX FDX | Allengers Medical Systems Limited | 2017 | — |
| +1 | K141736 | Philips Prograde; Philips Eleva Workspot for Digital Diagnost | Philips Medical Systems Dmc GmbH | 2014 | 6 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2013 | 4 | 0 |
| 2014 | 4 | 0 |
| 2016 | 2 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 6 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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? (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 |
|---|---|---|---|
| * | K982795 | Philips Bucky VisionSummary page 2…considered substantially equivalent to the Pixium 4600 detector, which received FDA clearance on November 24, 1998, under the name Philips Bucky Vision in 510(k) Number K982795. The grid supression pre-processing is equivalent to the pre-processing used by the Konica Minolta Regius Console CS 2000/CS-300… | 1998 |
| † | K051523 | Regius Console CS-2000 and Regius Console CS-3000, Medical Image Processing Workstation | 2005 |
| † | K063781 | Philips XD-S Direct Radiography Workstation/Package | 2007 |
What descends from it? (41)
See all 417 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112132 | Krystalrad 660 Digital Radiographic Portable Retrofit System | 2011 | 14 |
| K141736 | Philips Prograde; Philips Eleva Workspot for Digital Diagnost | 2014 | 6 |
| K102615 | Wireless DR Imaging Option-WDR1 | 2010 | 6 |
| K111725 | Mobilediagnost WDR | 2011 | 4 |
| K100400 | Prestodr Portable | 2010 | 3 |
| K131483 | Philips Pixium 4343RC | 2013 | 1 |
| K091752 | Viztek WL | 2009 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 27, 2018 | Class II | Z-2851-2018 | Device Design | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient. |
| Jun 27, 2018 | Class II | Z-2867-2018 | Device Design | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient. |
| Jun 27, 2018 | Class II | Z-2849-2018 | Device Design | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient. |
| Jun 27, 2018 | Class II | Z-2843-2018 | Device Design | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient. |
| Jun 27, 2018 | Class II | Z-2847-2018 | Device Design | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient. |
| Jun 27, 2018 | Class II | Z-2863-2018 | Device Design | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient. |
| Jun 27, 2018 | Class II | Z-2858-2018 | Device Design | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient. |
| Jun 27, 2018 | Class II | Z-2861-2018 | Device Design | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient. |
| Jun 27, 2018 | Class II | Z-2866-2018 | Device Design | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient. |
| Jun 27, 2018 | Class II | Z-2846-2018 | Device Design | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient. |
| Jun 27, 2018 | Class II | Z-2859-2018 | Device Design | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient. |
| Jun 27, 2018 | Class II | Z-2860-2018 | Device Design | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient. |
| Jun 27, 2018 | Class II | Z-2855-2018 | Device Design | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient. |
| Jun 27, 2018 | Class II | Z-2848-2018 | Device Design | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient. |
| Jun 27, 2018 | Class II | Z-2857-2018 | Device Design | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient. |
| Jun 27, 2018 | Class II | Z-2868-2018 | Device Design | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient. |
| Jun 27, 2018 | Class II | Z-2842-2018 | Device Design | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient. |
| Jun 27, 2018 | Class II | Z-2852-2018 | Device Design | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient. |
| Jun 27, 2018 | Class II | Z-2841-2018 | Device Design | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient. |
| Jun 27, 2018 | Class II | Z-2856-2018 | Device Design | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient. |
| Jun 27, 2018 | Class II | Z-2862-2018 | Device Design | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient. |
| Jun 27, 2018 | Class II | Z-2865-2018 | Device Design | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient. |
| Jun 27, 2018 | Class II | Z-2850-2018 | Device Design | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient. |
| Jun 27, 2018 | Class II | Z-2844-2018 | Device Design | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient. |
| Jun 27, 2018 | Class II | Z-2845-2018 | Device Design | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient. |
| Jun 27, 2018 | Class II | Z-2853-2018 | Device Design | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient. |
| Jun 27, 2018 | Class II | Z-2864-2018 | Device Design | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient. |
| Jun 27, 2018 | Class II | Z-2854-2018 | Device Design | The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient. |
The 5 latest of 28 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 10.3 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K112132 (Medicatech USA, 2011) has gone furthest, with 14 descendants of its own.
- 10 other devices also cite its predicate K982795.
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. 2009, 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?
As a part of a radiographic system, the Wireless Portable Detector FD-W17 is intended to acquire digital radiographic images. The Wireless Portable Detector FD-W17 is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding fluoroscopy, angiography and mammography.
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/K090625 · printed Nov 5, 2026
Cite this page
510(k) Report. “K090625: Wireless Portable Detector FD-W17.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K090625
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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