510(k) · Cleared
Recalled · Class II · 2013Philips Essenta DR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems GmbH, Dmc · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Mar 9, 2007 after a 14-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 1 later device descends from it. It has been recalled 4 times.
- Decided
- Mar 9, 2007
- Review
- 14 days
- Class
- Class II
- Product code
- MQB
- Recalls
- 4
- Predicates
- 1
1 later device descends from it, 1 citing it directly.
- This deviceK070528 Philips Essenta DRPhilips Medical Systems GmbH, Dmc · 2007
- Descendant · cites it directly · 0 of its ownK133496 X Twin SystemRoesys GmbH · 2014
Most influential descendants
Showing 1 of 1 · See all- K133496X Twin SystemRoesys GmbH · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K070528 | Philips Essenta DR | Philips Medical Systems GmbH, Dmc | 2007 | — |
| +1 | K133496 | X Twin System | Roesys GmbH | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K982795 | FDA’s K982795 is Philips Bucky Vision Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1998 |
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 |
|---|---|---|---|
| K133496 | X Twin System | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 5, 2013 | Class II | Z-0584-2014 | Nonconforming Material/Component | X-ray system C-arm casting may loosen and fall |
| Jul 25, 2012 | Class II | Z-2207-2012 | Equipment maintenance | Essenta DR C-Arm may fall |
| Aug 15, 2008 | Not classified | Z-0012-2011 | Other | When a patient is selected in the patient list and examination tab pressed with background query running at the same time, the wrong patient may be selected. |
| Apr 8, 2008 | Not classified | Z-1895-2008 | Software design | Bright artifacts may appear on a patient image from a previous exposure, which might lead to a misdiagnosis. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K133496 (Roesys GmbH, 2014) has gone furthest, with 0 descendants 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. 2007, 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 Essenta DR is a digital multifunctional X-ray system, suitable for all routine radiographic exams, including specialist areas like trauma or pediatric work, excluding mammography.
It is designed for radiographic examination of the standing or seated patient or the recumbent patient in combination with a mobile x-ray table (trolley).
The system is intended for direct digital imaging using the built in flat panel detector and in addition for free exposures on radiographic cassettes.
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/K070528 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070528: Philips Essenta DR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070528
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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