510(k) · Cleared
ClearedAgfa Computed Radiography Systems with NX2008 Workstations
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agfa Healthcare Corporation · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Jul 25, 2008 as substantially equivalent to K071162 (Agfa Healthcare Corp., 2007) after a 15-day review. Its family tree reaches back 2 generations to 2006. 37 later devices descend from it.
- Decided
- Jul 25, 2008
- Review
- 15 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K053634 (2006). 37 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK053634 Computed Radiography System with NX 1.0 WorkstationAgfa Corporation · 2006
- 1 generation backK071162 Agfa Computed Radiography System with NX2.X WorkstationsAgfa Healthcare Corp. · 2007 · Recalled
- This deviceK081963 Agfa Computed Radiography Systems with NX2008 WorkstationsAgfa Healthcare Corporation · 2008
- Descendant · cites it directly · 36 of its ownK090672 Agfa Computed Radiography Systems with NX WorkstationsAgfa Healthcare N.V. · 2009 · Recalled
- Descendant · 2 generations on · 34 of its ownK092669 DX-D Imaging PackageAgfa Healthcare N.V. · 2009 · Recalled
- Descendant · 2 generations on · 25 of its ownK122736 DX-D Imaging PackageAgfa Healthcare N.V. · 2013
- Descendant · 3 generations on · 15 of its ownK140771 Philips Eleva WorkspotPhilips Medical Systems Dmc GmbH · 2014
- Descendant · 3 generations on · 8 of its ownK103050 DX-D 300Agfa Healthcare N.V. · 2010
Showing 5 of 37 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 37 · See all- K090672Agfa Computed Radiography Systems with NX WorkstationsAgfa Healthcare N.V. · 2009 · cites it directly36descendants
- K092669DX-D Imaging PackageAgfa Healthcare N.V. · 2009 · 2 generations on34descendants
- K122736DX-D Imaging PackageAgfa Healthcare N.V. · 2013 · 2 generations on25descendants
- K140771Philips Eleva WorkspotPhilips Medical Systems Dmc GmbH · 2014 · 3 generations on15descendants
- K103050DX-D 300Agfa Healthcare N.V. · 2010 · 3 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K053634 | Computed Radiography System with NX 1.0 Workstation | Agfa Corporation | 2006 | — |
| −1 | K071162 | Agfa Computed Radiography System with NX2.X Workstations | Agfa Healthcare Corp. | 2007 | 2 |
| 0 (this device) | 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 |
| +2 | K092669 | DX-D Imaging Package | Agfa Healthcare N.V. | 2009 | 1 |
| +2 | K122736 | DX-D Imaging Package | Agfa Healthcare N.V. | 2013 | — |
| +3 | K140771 | Philips Eleva Workspot | Philips Medical Systems Dmc GmbH | 2014 | — |
| +3 | K103050 | DX-D 300 | Agfa Healthcare N.V. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K071162 | Agfa Computed Radiography System with NX2.X WorkstationsSummary page 1…his is a 510(k) for Agfa's computed Radiography Systems with NX 2008 Workstations. The predicate devices are Agfa’s Computed Radiography Systems with NX2.0 Workstations (K071162). B. DEVICE DESCRIPTION The predicate and new devices are nearly identical computed radiography imaging systems. NX 2008 system… | 2007 |
What descends from it? (37)
See all 371 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K090672 | Agfa Computed Radiography Systems with NX Workstations | 2009 | 36 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 2 years and passes through 3 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K090672 (Agfa Healthcare N.V., 2009) has gone furthest, with 36 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. 2008, 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 Radlography Systems with NX 2008 software are indicated for use in providing diagnostic quality images to aid the physiclan with diagnosis. The systems can be used with either Musica, Musica® or Musica® Platinum image processing to create radiographic images of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts. When used with separately cleared accessories the systems can be conveniently…
Read the full statement (126 words)
Agfa's Computed Radlography Systems with NX 2008 software are indicated for use in providing diagnostic quality images to aid the physiclan with diagnosis.
The systems can be used with either Musica, Musica® or Musica® Platinum image processing to create radiographic images of the skeleton (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 Muslca® Platinum software the systems are indicated for creating high quality Images of the thorax, abdomen or musculoskeletal regions of adult or padiatric patients.
Agfa's Computed Radiography Systems with NX 2008 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/K081963 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081963: Agfa Computed Radiography Systems with NX2008 Workstations.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081963
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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