510(k) · Cleared
ClearedSkyPlate Detector for Philips Radiography/Fluoroscopy Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems Dmc GmbH · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Jul 7, 2017 as substantially equivalent to K141736 (Philips Medical Systems Dmc GmbH, 2014) after a 50-day review. Its family tree reaches back 9 generations to 1981. 1 later device descends from it.
- Decided
- Jul 7, 2017
- Review
- 50 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K803130 (1981). 29 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 9 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 5 generations between
- 3 generations backK122736 DX-D Imaging PackageAgfa Healthcare N.V. · 2013
- 2 generations backK140771 Philips Eleva WorkspotPhilips Medical Systems Dmc GmbH · 2014
- 1 generation backK141736 Philips Prograde; Philips Eleva Workspot for Digital DiagnostPhilips Medical Systems Dmc GmbH · 2014 · Recalled
- This deviceK171461 SkyPlate Detector for Philips Radiography/Fluoroscopy SystemsPhilips Medical Systems Dmc GmbH · 2017
- Descendant · cites it directly · 0 of its ownK210985 1717FCCRayence Co., Ltd. · 2021
Show all 9 generations
- Root · 9 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 8 generations backK971452 Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997 · Recalled
- 7 generations backK983732 Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- 6 generations backK992794 Stingray DR, Model 1Infimed, Inc. · 1999
- 5 generations backK024147 Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003
- 4 generations backK092669 DX-D Imaging PackageAgfa Healthcare N.V. · 2009 · Recalled
- 3 generations backK122736 DX-D Imaging PackageAgfa Healthcare N.V. · 2013
- 2 generations backK140771 Philips Eleva WorkspotPhilips Medical Systems Dmc GmbH · 2014
- 1 generation backK141736 Philips Prograde; Philips Eleva Workspot for Digital DiagnostPhilips Medical Systems Dmc GmbH · 2014 · Recalled
- This deviceK171461 SkyPlate Detector for Philips Radiography/Fluoroscopy SystemsPhilips Medical Systems Dmc GmbH · 2017
Most influential descendants
Showing 1 of 1 · See all- K2109851717FCCRayence Co., Ltd. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K803130 | Multix U. Bucky Table X-Ray Unit | Siemens Corp. | 1981 | 1 |
| −8 | K971452 | Multix Top/Pro Radiographic X-Ray Table | Siemens Medical Solutions USA, Inc. | 1997 | 8 |
| −7 | K983732 | Thorax FD and Multix FD | Siemens Medical Solutions USA, Inc. | 1999 | 1 |
| −6 | K992794 | Stingray DR, Model 1 | Infimed, Inc. | 1999 | — |
| −5 | K024147 | Paxscan 4030 Medical Digital Imaging System | Varian Medical Systems, Inc. | 2003 | — |
| −4 | K092669 | DX-D Imaging Package | Agfa Healthcare N.V. | 2009 | 1 |
| −3 | K122736 | DX-D Imaging Package | Agfa Healthcare N.V. | 2013 | — |
| −2 | K140771 | Philips Eleva Workspot | Philips Medical Systems Dmc GmbH | 2014 | — |
| −1 | K141736 | Philips Prograde; Philips Eleva Workspot for Digital Diagnost | Philips Medical Systems Dmc GmbH | 2014 | 6 |
| 0 (this device) | K171461 | SkyPlate Detector for Philips Radiography/Fluoroscopy Systems | Philips Medical Systems Dmc GmbH | 2017 | — |
| +1 | K210985 | 1717FCC | Rayence Co., Ltd. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 2000 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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.
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 |
|---|---|---|---|
| K210985 | 1717FCC | 2021 | 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 36 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- 17 of the 29 ancestors have a recall of any class.
- Of its descendants, K210985 (Rayence Co., Ltd., 2021) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K141736.
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. 2017, 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 SkyPlate Detector for Philips Radiography/Fluoroscopy Systems is intended to acquire, process, store, display and export digital radiographic images. The SkyPlate Detector for Philips Radiography/Fluoroscopy Systems is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171461 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171461: SkyPlate Detector for Philips Radiography/Fluoroscopy Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171461
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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