510(k) · Cleared
Recalled · Class II · 2026DigitalDiagnost C90
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 Sep 30, 2020 as substantially equivalent to K182973 (Philips Medical Systems Dmc GmbH, 2019) after a 26-day review. Its family tree reaches back 10 generations to 1981. 2 later devices descend from it. It has been recalled 8 times.
- Decided
- Sep 30, 2020
- Review
- 26 days
- Class
- Class II
- Product code
- MQB
- Recalls
- 8
- Predicates
- 1
Its longest line of descent runs back 10 generations to K803130 (1981). 30 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 10 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 6 generations between
- 3 generations backK140771 Philips Eleva WorkspotPhilips Medical Systems Dmc GmbH · 2014
- 2 generations backK141736 Philips Prograde; Philips Eleva Workspot for Digital DiagnostPhilips Medical Systems Dmc GmbH · 2014 · Recalled
- 1 generation backK182973 DigitalDiagnost C90Philips Medical Systems Dmc GmbH · 2019
- This deviceK202564 DigitalDiagnost C90Philips Medical Systems Dmc GmbH · 2020
- Descendant · cites it directly · 1 of its ownK210692 DigitalDiagnostPhilips Medical Systems Dmc GmbH · 2021 · Recalled
- Descendant · 2 generations on · 0 of its ownK212186 Philips Radiology Smart AssistantPhilips Medical Systems Dmc GmbH · 2021
Show all 10 generations
- Root · 10 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 9 generations backK971452 Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997 · Recalled
- 8 generations backK983732 Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- 7 generations backK992794 Stingray DR, Model 1Infimed, Inc. · 1999
- 6 generations backK024147 Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003
- 5 generations backK092669 DX-D Imaging PackageAgfa Healthcare N.V. · 2009 · Recalled
- 4 generations backK122736 DX-D Imaging PackageAgfa Healthcare N.V. · 2013
- 3 generations backK140771 Philips Eleva WorkspotPhilips Medical Systems Dmc GmbH · 2014
- 2 generations backK141736 Philips Prograde; Philips Eleva Workspot for Digital DiagnostPhilips Medical Systems Dmc GmbH · 2014 · Recalled
- 1 generation backK182973 DigitalDiagnost C90Philips Medical Systems Dmc GmbH · 2019
- This deviceK202564 DigitalDiagnost C90Philips Medical Systems Dmc GmbH · 2020
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K803130 | Multix U. Bucky Table X-Ray Unit | Siemens Corp. | 1981 | 1 |
| −9 | K971452 | Multix Top/Pro Radiographic X-Ray Table | Siemens Medical Solutions USA, Inc. | 1997 | 8 |
| −8 | K983732 | Thorax FD and Multix FD | Siemens Medical Solutions USA, Inc. | 1999 | 1 |
| −7 | K992794 | Stingray DR, Model 1 | Infimed, Inc. | 1999 | — |
| −6 | K024147 | Paxscan 4030 Medical Digital Imaging System | Varian Medical Systems, Inc. | 2003 | — |
| −5 | K092669 | DX-D Imaging Package | Agfa Healthcare N.V. | 2009 | 1 |
| −4 | K122736 | DX-D Imaging Package | Agfa Healthcare N.V. | 2013 | — |
| −3 | K140771 | Philips Eleva Workspot | Philips Medical Systems Dmc GmbH | 2014 | — |
| −2 | K141736 | Philips Prograde; Philips Eleva Workspot for Digital Diagnost | Philips Medical Systems Dmc GmbH | 2014 | 6 |
| −1 | K182973 | DigitalDiagnost C90 | Philips Medical Systems Dmc GmbH | 2019 | — |
| 0 (this device) | K202564 | DigitalDiagnost C90 | Philips Medical Systems Dmc GmbH | 2020 | — |
| +1 | K210692 | DigitalDiagnost | Philips Medical Systems Dmc GmbH | 2021 | 8 |
| +2 | 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 |
|---|---|---|
| 2021 | 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.
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K210692 | DigitalDiagnost | 2021 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 1, 2026 | Class II | Z-2354-2026 | Device Design | System was delivered without the required Seismic kit for Wall Stand VS2, which is designed to prevent damage and ensure stability of the Wall Stand VS2 during seismic events. |
| Oct 1, 2025 | Class II | Z-0465-2026 | Device Design | Philips has identified that some ceiling suspension telescopic carriages manufactured from July 2024 through June 2025 may be difficult to move vertically (i.e. additional force/physical exertion required for manual movement) due to… |
| Sep 21, 2023 | Class II | Z-0275-2024 | Under Investigation by firm | Potential for units suspended on the ceiling to fail and fall. |
| Sep 21, 2023 | Class II | Z-0276-2024 | Under Investigation by firm | Potential for units suspended on the ceiling to fail and fall. |
| May 19, 2023 | Class II | Z-2042-2023 | Software change control | There is a software login in issue that may prevent the user from logging in. |
| Sep 22, 2021 | Class II | Z-0239-2022 | Radiation Control for Health and Safety Act | The Aleva monitor requires certain labels to be applied, some of which are required by FDA Electronic Product Radiation Control performance standards. This includes the Radiation Warning Label [21CFR 1020.30 (j)] and the X-ray control… |
| May 19, 2021 | Class II | Z-1328-2022 | Radiation Control for Health and Safety Act | Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of image on the first examination due to an issue in the firmware of the… |
| May 19, 2021 | Class II | Z-1329-2022 | Radiation Control for Health and Safety Act | Following a system restart where the Table Height 2 (TH2) is the default setting and then switched to Wallstand VS2, operators will see an incorrect orientation of image on the first examination due to an issue in the firmware of the… |
The 5 latest of 8 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 39 years and passes through 6 companies; a new generation was cleared every 3.3 years on median.
- 17 of the 30 ancestors have a recall of any class.
- Of its descendants, K210692 (Philips Medical Systems Dmc GmbH, 2021) has gone furthest, with 1 descendant of its own.
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. 2020, 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 DigitalDiagnost C90 is intended to acquire, process, store, display and export digital radiographic images. The DigitalDiagnost C90 is suitable for all routine radiography examinations, 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/K202564 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202564: DigitalDiagnost C90.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202564
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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