510(k) · Cleared
Recalled · Class II · 2018Philips Prograde; Philips Eleva Workspot for Digital Diagnost
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 25, 2014 as substantially equivalent to K140771 (Philips Medical Systems Dmc GmbH, 2014) and 1 other predicate after a 28-day review. Its family tree reaches back 8 generations to 1981. 6 later devices descend from it. It has been recalled 6 times.
- Decided
- Jul 25, 2014
- Review
- 28 days
- Class
- Class II
- Product code
- MQB
- Recalls
- 6
- Predicates
- 2
Its longest line of descent runs back 8 generations to K803130 (1981). 28 ancestors in all. 6 later devices descend from it, 2 citing it directly.
- Root · 8 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 7 generations backK971452 Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997 · Recalled
- 6 generations backK983732 Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- 5 generations backK992794 Stingray DR, Model 1Infimed, Inc. · 1999
- 4 generations backK024147 Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003
- 3 generations backK092669 DX-D Imaging PackageAgfa Healthcare N.V. · 2009 · Recalled
- 2 generations backK122736 DX-D Imaging PackageAgfa Healthcare N.V. · 2013
- 1 generation backK140771 Philips Eleva WorkspotPhilips Medical Systems Dmc GmbH · 2014
- This deviceK141736 Philips Prograde; Philips Eleva Workspot for Digital DiagnostPhilips Medical Systems Dmc GmbH · 2014
- Descendant · cites it directly · 3 of its ownK182973 DigitalDiagnost C90Philips Medical Systems Dmc GmbH · 2019
- Descendant · 2 generations on · 2 of its ownK202564 DigitalDiagnost C90Philips Medical Systems Dmc GmbH · 2020 · Recalled
- Descendant · 3 generations on · 1 of its ownK210692 DigitalDiagnostPhilips Medical Systems Dmc GmbH · 2021 · Recalled
- Descendant · cites it directly · 1 of its ownK171461 SkyPlate Detector for Philips Radiography/Fluoroscopy SystemsPhilips Medical Systems Dmc GmbH · 2017
- Descendant · 4 generations on · 0 of its ownK212186 Philips Radiology Smart AssistantPhilips Medical Systems Dmc GmbH · 2021
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K182973DigitalDiagnost C90Philips Medical Systems Dmc GmbH · 2019 · cites it directly3descendants
- K202564DigitalDiagnost C90Philips Medical Systems Dmc GmbH · 2020 · 2 generations on2descendants
- K210692DigitalDiagnostPhilips Medical Systems Dmc GmbH · 2021 · 3 generations on1descendant
- K171461SkyPlate Detector for Philips Radiography/Fluoroscopy SystemsPhilips Medical Systems Dmc GmbH · 2017 · cites it directly1descendant
- K212186Philips Radiology Smart AssistantPhilips Medical Systems Dmc GmbH · 2021 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K803130 | Multix U. Bucky Table X-Ray Unit | Siemens Corp. | 1981 | 1 |
| −7 | K971452 | Multix Top/Pro Radiographic X-Ray Table | Siemens Medical Solutions USA, Inc. | 1997 | 8 |
| −6 | K983732 | Thorax FD and Multix FD | Siemens Medical Solutions USA, Inc. | 1999 | 1 |
| −5 | K992794 | Stingray DR, Model 1 | Infimed, Inc. | 1999 | — |
| −4 | K024147 | Paxscan 4030 Medical Digital Imaging System | Varian Medical Systems, Inc. | 2003 | — |
| −3 | K092669 | DX-D Imaging Package | Agfa Healthcare N.V. | 2009 | 1 |
| −2 | K122736 | DX-D Imaging Package | Agfa Healthcare N.V. | 2013 | — |
| −1 | K140771 | Philips Eleva Workspot | Philips Medical Systems Dmc GmbH | 2014 | — |
| 0 (this device) | K141736 | Philips Prograde; Philips Eleva Workspot for Digital Diagnost | Philips Medical Systems Dmc GmbH | 2014 | — |
| +1 | K182973 | DigitalDiagnost C90 | Philips Medical Systems Dmc GmbH | 2019 | — |
| +2 | K202564 | DigitalDiagnost C90 | Philips Medical Systems Dmc GmbH | 2020 | 8 |
| +3 | K210692 | DigitalDiagnost | Philips Medical Systems Dmc GmbH | 2021 | 8 |
| +1 | K171461 | SkyPlate Detector for Philips Radiography/Fluoroscopy Systems | Philips Medical Systems Dmc GmbH | 2017 | — |
| +4 | K212186 | Philips Radiology Smart Assistant | Philips Medical Systems Dmc GmbH | 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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 3 | 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 |
|---|---|---|---|
| * | K140771 | Philips Eleva WorkspotSummary page 1…Philips Medical Systems DMC GmbH 5 10O(k) Clearance: K 14077 1; April 25, 2014 Product codes MQB. LLZ Classification Nam… | 2014 |
| * | K090625 | Wireless Portable Detector FD-W17Summary page 1…Philips Medical Systems DMC GmbH 5 10(k) Clearance: K090625, March 24, 2009 Product code MQB Philips Eleva Workspot with SkyPlate Dete… | 2009 |
What descends from it? (6)
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 |
|---|---|---|---|---|
| Sep 19, 2018 | Class II | Z-0239-2019 | Software design | Stitching run on SkyPlate detector interrupted intermittently; Stitching with SkyPlate aborts after first image; System software CD contains wrong baseline |
| Dec 11, 2017 | Class II | Z-0704-2018 | Under Investigation by firm | It the WiFi connection between the SkyPlate detector and HP transfer point is weak, an image may fail to transfer from the SkyPlate detector to the system. The image remains in the memory of the detector, but cannot be transferred… |
| May 11, 2017 | Class II | Z-2154-2017 | Software design | During recent evaluations of the Philips DigitalDiagnost 3.1.x, we have identified a potential issue that may affect the performance of the equipment under certain conditions. |
| Nov 10, 2015 | Class II | Z-1695-2016 | Radiation Control for Health and Safety Act | The detector may signal that it is ready for acquisition when it actually is not, resulting in failure to properly acquire the X-ray image. |
| Mar 23, 2015 | Class II | Z-2383-2015 | Radiation Control for Health and Safety Act | The system is designed to emit a beep upon termination of an exposure. However, if the system has been powered on for over 12 hours, the system will no longer emit this signal due to a defect in the Microsoft Windows 7 operating system. |
| Feb 9, 2015 | Class II | Z-1554-2015 | Software design (manufacturing process) | The system is designed to emit a beep upon termination of an exposure. However, if the system has been powered on for over 12 hours, the system will no longer emit this signal. This is a failure to comply with 21CFR 1020.31(j). |
The 5 latest of 6 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 33 years and passes through 6 companies; a new generation was cleared every 3.3 years on median.
- 16 of the 28 ancestors have a recall of any class.
- Of its descendants, K182973 (Philips Medical Systems Dmc GmbH, 2019) has gone furthest, with 3 descendants of its own.
- 3 other devices also cite its predicate K140771.
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. 2014, 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 Philips Eleva Workspot with SkyPlate Detectors is intended to acquire, process, store, display, and export digital radiographic images. The Philips Eleva Workspot with SkyPlate Detectors 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 as stated in the FDA summary.
https://510kreport.com/device/K141736 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141736: Philips Prograde; Philips Eleva Workspot for Digital Diagnost.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141736
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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