510(k) · Cleared
Recalled · Class II · 2016Agfa Computed Radiography Systems with NX Workstations
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agfa Healthcare N.V. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on May 18, 2009 as substantially equivalent to K081963 (Agfa Healthcare Corporation, 2008) after a 66-day review. Its family tree reaches back 3 generations to 2006. 36 later devices descend from it. It has been recalled 2 times.
- Decided
- May 18, 2009
- Review
- 66 days
- Class
- Class II
- Product code
- MQB
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 3 generations to K053634 (2006). 36 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK053634 Computed Radiography System with NX 1.0 WorkstationAgfa Corporation · 2006
- 2 generations backK071162 Agfa Computed Radiography System with NX2.X WorkstationsAgfa Healthcare Corp. · 2007 · Recalled
- 1 generation backK081963 Agfa Computed Radiography Systems with NX2008 WorkstationsAgfa Healthcare Corporation · 2008
- This deviceK090672 Agfa Computed Radiography Systems with NX WorkstationsAgfa Healthcare N.V. · 2009
- Descendant · cites it directly · 34 of its ownK092669 DX-D Imaging PackageAgfa Healthcare N.V. · 2009 · Recalled
- Descendant · cites it directly · 25 of its ownK122736 DX-D Imaging PackageAgfa Healthcare N.V. · 2013
- Descendant · 2 generations on · 15 of its ownK140771 Philips Eleva WorkspotPhilips Medical Systems Dmc GmbH · 2014
- Descendant · 2 generations on · 8 of its ownK103050 DX-D 300Agfa Healthcare N.V. · 2010
- Descendant · 2 generations on · 7 of its ownK141192 DR 400Agfa Healthcare N.V. · 2014
Showing 5 of 36 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 36 · See all- K092669DX-D Imaging PackageAgfa Healthcare N.V. · 2009 · cites it directly34descendants
- K122736DX-D Imaging PackageAgfa Healthcare N.V. · 2013 · cites it directly25descendants
- K140771Philips Eleva WorkspotPhilips Medical Systems Dmc GmbH · 2014 · 2 generations on15descendants
- K103050DX-D 300Agfa Healthcare N.V. · 2010 · 2 generations on8descendants
- K141192DR 400Agfa Healthcare N.V. · 2014 · 2 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K053634 | Computed Radiography System with NX 1.0 Workstation | Agfa Corporation | 2006 | — |
| −2 | K071162 | Agfa Computed Radiography System with NX2.X Workstations | Agfa Healthcare Corp. | 2007 | 2 |
| −1 | K081963 | Agfa Computed Radiography Systems with NX2008 Workstations | Agfa Healthcare Corporation | 2008 | — |
| 0 (this device) | K090672 | Agfa Computed Radiography Systems with NX Workstations | Agfa Healthcare N.V. | 2009 | — |
| +1 | K092669 | DX-D Imaging Package | Agfa Healthcare N.V. | 2009 | 1 |
| +1 | K122736 | DX-D Imaging Package | Agfa Healthcare N.V. | 2013 | — |
| +2 | K140771 | Philips Eleva Workspot | Philips Medical Systems Dmc GmbH | 2014 | — |
| +2 | K103050 | DX-D 300 | Agfa Healthcare N.V. | 2010 | — |
| +2 | K141192 | DR 400 | Agfa Healthcare N.V. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 5 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 7 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K081963 | Agfa Computed Radiography Systems with NX2008 WorkstationsSummary page 1…This is a 510(k) for Agfa’s Computed Radiography Systems with NX Workstations. The predicate devices are Agfa’s Computed Radiography Systems with NX2008 Workstations (K081963). B. DEVICE DESCRIPTION The predicate and new devices are nearly identical computed radiography imaging systems. New NX workst… | 2008 |
What descends from it? (36)
See all 363 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 |
|---|---|---|---|---|
| Dec 21, 2016 | Class II | Z-2735-2017 | Device Design | A customer reported that when using an NX workstation with software version NX 3.0.8950 software and selecting the affected patient/exam from closed exams, initially the wrong image was linked to the exam and appeared. After a short time… |
| Jun 22, 2009 | Not classified | Z-1889-2009 | Software design | After opening and closing a study on a Central Monitoring System while a study is still open on an in-room NX system, a problem of image mix-up can occur on the in-room NX system. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 3 years and passes through 4 companies; a new generation was cleared every 1.2 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K092669 (Agfa Healthcare N.V., 2009) has gone furthest, with 34 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. 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?
Agfa’s Computed Radiography Systems with NX Workstations are indicated for use in providing diagnostic quality images to aid the physician with diagnosis.
Systems can be used with either Musica or Musica® image processing to create radiographic images of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts.
System options and accessories are available for:
• Pediatric imaging
• Full leg/full spine
• Radiotherapy planning and QC
• Musica® Platinum (thorax, abdomen or musculoskeletal regions of adult or pediatric patients)
• Musica® Neonatal
Agfa's Computed Radiography Systems with NX Workstations are not indicated for use in 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/K090672 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090672: Agfa Computed Radiography Systems with NX Workstations.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090672
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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