510(k) · Cleared
ClearedComputed Radiography System with NX 1.0 Workstation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agfa Corporation · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Jan 17, 2006 after a 19-day review. The FDA summary names its predicate without a number. 46 later devices descend from it.
- Decided
- Jan 17, 2006
- Review
- 19 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 0
46 later devices descend from it, 3 citing it directly.
- This deviceK053634 Computed Radiography System with NX 1.0 WorkstationAgfa Corporation · 2006
- Descendant · cites it directly · 38 of its ownK071162 Agfa Computed Radiography System with NX2.X WorkstationsAgfa Healthcare Corp. · 2007 · Recalled
- Descendant · 2 generations on · 37 of its ownK081963 Agfa Computed Radiography Systems with NX2008 WorkstationsAgfa Healthcare Corporation · 2008
- Descendant · 3 generations on · 36 of its ownK090672 Agfa Computed Radiography Systems with NX WorkstationsAgfa Healthcare N.V. · 2009 · Recalled
- Descendant · 4 generations on · 34 of its ownK092669 DX-D Imaging PackageAgfa Healthcare N.V. · 2009 · Recalled
- Descendant · 4 generations on · 25 of its ownK122736 DX-D Imaging PackageAgfa Healthcare N.V. · 2013
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 46 · See all- K071162Agfa Computed Radiography System with NX2.X WorkstationsAgfa Healthcare Corp. · 2007 · cites it directly38descendants
- K081963Agfa Computed Radiography Systems with NX2008 WorkstationsAgfa Healthcare Corporation · 2008 · 2 generations on37descendants
- K090672Agfa Computed Radiography Systems with NX WorkstationsAgfa Healthcare N.V. · 2009 · 3 generations on36descendants
- K092669DX-D Imaging PackageAgfa Healthcare N.V. · 2009 · 4 generations on34descendants
- K122736DX-D Imaging PackageAgfa Healthcare N.V. · 2013 · 4 generations on25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 |
| +2 | K081963 | Agfa Computed Radiography Systems with NX2008 Workstations | Agfa Healthcare Corporation | 2008 | — |
| +3 | K090672 | Agfa Computed Radiography Systems with NX Workstations | Agfa Healthcare N.V. | 2009 | 2 |
| +4 | K092669 | DX-D Imaging Package | Agfa Healthcare N.V. | 2009 | 1 |
| +4 | K122736 | DX-D Imaging Package | Agfa Healthcare N.V. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 2 | 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 | 4 | 0 |
| 2021 | 7 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 |
|---|---|---|---|
| * | — | Agfa's Computed Radiography System with QS 3.0 workstation Named without a submission number |
What descends from it? (46)
See all 463 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)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K071162 (Agfa Healthcare Corp., 2007) has gone furthest, with 38 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.
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 NX1.0 workstations are indicated to provide diagnostic quality images to aid the physician with diagnosis.
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/K053634 · printed Nov 6, 2026
Cite this page
510(k) Report. “K053634: Computed Radiography System with NX 1.0 Workstation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K053634
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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