510(k) · Cleared
Recalled · 2011Agfa Computed Radiography Systems with DX-G Digitizers
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 Aug 11, 2009 as substantially equivalent to K090672 (Agfa Healthcare N.V., 2009) after a 19-day review. Its family tree reaches back 4 generations to 2006. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Aug 11, 2009
- Review
- 19 days
- Class
- Class II
- Product code
- MQB
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 4 generations to K053634 (2006). 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK053634 Computed Radiography System with NX 1.0 WorkstationAgfa Corporation · 2006
- 3 generations backK071162 Agfa Computed Radiography System with NX2.X WorkstationsAgfa Healthcare Corp. · 2007 · Recalled
- 2 generations backK081963 Agfa Computed Radiography Systems with NX2008 WorkstationsAgfa Healthcare Corporation · 2008
- 1 generation backK090672 Agfa Computed Radiography Systems with NX WorkstationsAgfa Healthcare N.V. · 2009 · Recalled
- This deviceK092238 Agfa Computed Radiography Systems with DX-G DigitizersAgfa Healthcare N.V. · 2009
- Descendant · cites it directly · 0 of its ownK141602 DX-D Imaging PackageAgfa Healthcare N.V. · 2014
Most influential descendants
Showing 1 of 1 · See all- K141602DX-D Imaging PackageAgfa Healthcare N.V. · 2014 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K053634 | Computed Radiography System with NX 1.0 Workstation | Agfa Corporation | 2006 | — |
| −3 | K071162 | Agfa Computed Radiography System with NX2.X Workstations | Agfa Healthcare Corp. | 2007 | 2 |
| −2 | K081963 | Agfa Computed Radiography Systems with NX2008 Workstations | Agfa Healthcare Corporation | 2008 | — |
| −1 | K090672 | Agfa Computed Radiography Systems with NX Workstations | Agfa Healthcare N.V. | 2009 | 2 |
| 0 (this device) | K092238 | Agfa Computed Radiography Systems with DX-G Digitizers | Agfa Healthcare N.V. | 2009 | — |
| +1 | K141602 | DX-D Imaging Package | Agfa Healthcare N.V. | 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K090672 | Agfa Computed Radiography Systems with NX WorkstationsSummary page 1…VICES This is a 510(k) for Agfa’s Computed Radiography Systems with DX-G Digitizers. The predicate devices are Agfa’s Computed Radiography Systems with NX Workstations (K090672). B. DEVICE DESCRIPTION The new devices are computed radiography imaging systems of similar design and construction to the pred… | 2009 |
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 |
|---|---|---|---|
| K141602 | DX-D Imaging Package | 2014 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 6, 2011 | Not classified | Z-0591-2012 | Software design | Occasionally images can be lost or sent to an incorrect folder or the digitizer may stop either during startup or during a cassette scan cycle. |
| Oct 8, 2010 | Not classified | Z-0464-2011 | Other | Packaging was switched between a DX-G Digitizer and a DX-M Digitizer, resulting in the wrong product, which is not sold in the US, being shipped to the consignee. |
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.
- 2 of the 4 ancestors have a recall of any class.
- Of its descendants, K141602 (Agfa Healthcare N.V., 2014) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K090672.
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 DX-G Digitizers 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 skulf, spinal column and extremities) chest, abdomen and other body parts.
System options and accessories are avaitable for:
Pediatric imaging
Full leg/full spine
Radiotherapy planning and QC
Musica® Platinum (thorax, abdomen or musculoskeletal regions of adult or pediatric patients)
e 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/K092238 · printed Nov 4, 2026
Cite this page
510(k) Report. “K092238: Agfa Computed Radiography Systems with DX-G Digitizers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K092238
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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