510(k) · Cleared
Recalled · 2011Agfa Computed Radiography System with NX2.X Workstations
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agfa Healthcare Corp. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on May 8, 2007 as substantially equivalent to K053634 (Agfa Corporation, 2006) after a 12-day review. Its family tree reaches back 1 generation to 2006. 38 later devices descend from it. It has been recalled 2 times.
- Decided
- May 8, 2007
- Review
- 12 days
- Class
- Class II
- Product code
- MQB
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K053634 (2006). 38 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK053634 Computed Radiography System with NX 1.0 WorkstationAgfa Corporation · 2006
- This deviceK071162 Agfa Computed Radiography System with NX2.X WorkstationsAgfa Healthcare Corp. · 2007
- Descendant · cites it directly · 37 of its ownK081963 Agfa Computed Radiography Systems with NX2008 WorkstationsAgfa Healthcare Corporation · 2008
- Descendant · 2 generations on · 36 of its ownK090672 Agfa Computed Radiography Systems with NX WorkstationsAgfa Healthcare N.V. · 2009 · Recalled
- Descendant · 3 generations on · 34 of its ownK092669 DX-D Imaging PackageAgfa Healthcare N.V. · 2009 · Recalled
- Descendant · 3 generations on · 25 of its ownK122736 DX-D Imaging PackageAgfa Healthcare N.V. · 2013
- Descendant · 4 generations on · 15 of its ownK140771 Philips Eleva WorkspotPhilips Medical Systems Dmc GmbH · 2014
Showing 5 of 38 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 38 · See all- K081963Agfa Computed Radiography Systems with NX2008 WorkstationsAgfa Healthcare Corporation · 2008 · cites it directly37descendants
- K090672Agfa Computed Radiography Systems with NX WorkstationsAgfa Healthcare N.V. · 2009 · 2 generations on36descendants
- K092669DX-D Imaging PackageAgfa Healthcare N.V. · 2009 · 3 generations on34descendants
- K122736DX-D Imaging PackageAgfa Healthcare N.V. · 2013 · 3 generations on25descendants
- K140771Philips Eleva WorkspotPhilips Medical Systems Dmc GmbH · 2014 · 4 generations on15descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K053634 | Computed Radiography System with NX 1.0 Workstation | Agfa Corporation | 2006 | — |
| 0 (this device) | K071162 | Agfa Computed Radiography System with NX2.X Workstations | Agfa Healthcare Corp. | 2007 | — |
| +1 | K081963 | Agfa Computed Radiography Systems with NX2008 Workstations | Agfa Healthcare Corporation | 2008 | — |
| +2 | K090672 | Agfa Computed Radiography Systems with NX Workstations | Agfa Healthcare N.V. | 2009 | 2 |
| +3 | K092669 | DX-D Imaging Package | Agfa Healthcare N.V. | 2009 | 1 |
| +3 | K122736 | DX-D Imaging Package | Agfa Healthcare N.V. | 2013 | — |
| +4 | K140771 | Philips Eleva Workspot | Philips Medical Systems Dmc GmbH | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 3 | 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 |
|---|---|---|---|
| * | K053634 | Computed Radiography System with NX 1.0 WorkstationSummary page 1…his is a 510(k) for Agfa’s computed Radiography Systems with NX 2.X Workstations. The predicate devices are Agfa's Computed Radiography Systems with NX1.0 workstations (K053634). B. DEVICE DESCRIPTION The predicate and new devices are nearly identical computed radiography imaging systems. NX 2.X systems… | 2006 |
What descends from it? (38)
See all 381 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081963 | Agfa Computed Radiography Systems with NX2008 Workstations | 2008 | 37 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 4, 2011 | Not classified | Z-2137-2011 | Other | When a radiographer is working on two open studies on an NX workstation and, in specific situations, a problem of image/annotation mix-up can occur on the NX system. |
| Jun 30, 2010 | Not classified | Z-2100-2010 | Other | Monitor fell from the mounting bracket used to support the monitor. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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?
Agfa’s Computed Radiography Systems with NX 2.X software are indicated for use in providing diagnostic quality images to aid the physician with diagnosis. The systems can be used with either Musica, Musica® or Musica® Platinum image processing to create radiographic images of the skelston (including skull, spinal column and extremities) chest, abdomen and other body parts. When used with separately cleared accessories the systems can be conveniently used…
Read the full statement (125 words)
Agfa’s Computed Radiography Systems with NX 2.X software are indicated for use in providing diagnostic quality images to aid the physician with diagnosis.
The systems can be used with either Musica, Musica® or Musica® Platinum image processing to create radiographic images of the skelston (including skull, spinal column and extremities) chest, abdomen and other body parts.
When used with separately cleared accessories the systems can be conveniently used to generate urological, tomographic, pediatric and dental images, and for radiotherapy planning and quality control.
When used with Musica® Platinum software the systems are indicated for creating high quality images of the thorax, abdomen or musculoskeletal regions of adult or pediatric patients.
Agfa’'s Computed Radiography Systems with NX 2.X software 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/K071162 · printed Nov 6, 2026
Cite this page
510(k) Report. “K071162: Agfa Computed Radiography System with NX2.X Workstations.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K071162
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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