510(k) · Cleared
ClearedDR 400
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 Jun 6, 2014 as substantially equivalent to K122736 (Agfa Healthcare N.V., 2013) and 1 other predicate after a 29-day review. Its family tree reaches back 7 generations to 1981. 7 later devices descend from it.
- Decided
- Jun 6, 2014
- Review
- 29 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K803130 (1981). 25 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 6 generations backK971452 Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997 · Recalled
- 5 generations backK983732 Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- 4 generations backK992794 Stingray DR, Model 1Infimed, Inc. · 1999
- 3 generations backK024147 Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003
- 2 generations backK092669 DX-D Imaging PackageAgfa Healthcare N.V. · 2009 · Recalled
- 1 generation backK122736 DX-D Imaging PackageAgfa Healthcare N.V. · 2013
- This deviceK141192 DR 400Agfa Healthcare N.V. · 2014
- Descendant · cites it directly · 6 of its ownK152639 DR 600Agfa Healthcare N.V. · 2015
- Descendant · 2 generations on · 4 of its ownK193262 DR 600 with TomosynthesisAgfa N.V. · 2020
- Descendant · 3 generations on · 3 of its ownK222934 Nanox.ARCNano-X Imaging, Ltd. · 2023
- Descendant · 4 generations on · 2 of its ownK242395 Nanox.ARCNano-X Imaging, Ltd. · 2024
- Descendant · 5 generations on · 1 of its ownK250850 Nanox.ARC XNano-X Imaging, Ltd. · 2025
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K152639DR 600Agfa Healthcare N.V. · 2015 · cites it directly6descendants
- K193262DR 600 with TomosynthesisAgfa N.V. · 2020 · 2 generations on4descendants
- K222934Nanox.ARCNano-X Imaging, Ltd. · 2023 · 3 generations on3descendants
- K242395Nanox.ARCNano-X Imaging, Ltd. · 2024 · 4 generations on2descendants
- K250850Nanox.ARC XNano-X Imaging, Ltd. · 2025 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K803130 | Multix U. Bucky Table X-Ray Unit | Siemens Corp. | 1981 | 1 |
| −6 | K971452 | Multix Top/Pro Radiographic X-Ray Table | Siemens Medical Solutions USA, Inc. | 1997 | 8 |
| −5 | K983732 | Thorax FD and Multix FD | Siemens Medical Solutions USA, Inc. | 1999 | 1 |
| −4 | K992794 | Stingray DR, Model 1 | Infimed, Inc. | 1999 | — |
| −3 | K024147 | Paxscan 4030 Medical Digital Imaging System | Varian Medical Systems, Inc. | 2003 | — |
| −2 | K092669 | DX-D Imaging Package | Agfa Healthcare N.V. | 2009 | 1 |
| −1 | K122736 | DX-D Imaging Package | Agfa Healthcare N.V. | 2013 | — |
| 0 (this device) | K141192 | DR 400 | Agfa Healthcare N.V. | 2014 | — |
| +1 | K152639 | DR 600 | Agfa Healthcare N.V. | 2015 | — |
| +2 | K193262 | DR 600 with Tomosynthesis | Agfa N.V. | 2020 | — |
| +3 | K222934 | Nanox.ARC | Nano-X Imaging, Ltd. | 2023 | — |
| +4 | K242395 | Nanox.ARC | Nano-X Imaging, Ltd. | 2024 | — |
| +5 | K250850 | Nanox.ARC X | Nano-X Imaging, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 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? (2)
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 |
|---|---|---|---|
| * | K122736 | DX-D Imaging PackageSummary page 1…ED PREDICATE DEVICES This is a 5 10(k) for Agfa's DR 400, a solid state x-ray imaging device. It is substantially equivalent to systems with Agfa's DX-D Imaging Package (K122736) and Sedecal USA's Optima URS (K012546). B. DEVICE DESCRIPTION Agfa's DR 400 is a solid state x-ray system, a direct radio… | 2013 |
| * | K012546 | Optima Urs Universal Radiographic SystemSummary page 1…for Agfa's DR 400, a solid state x-ray imaging device. It is substantially equivalent to systems with Agfa's DX-D Imaging Package (K122736) and Sedecal USA's Optima URS (K012546). B. DEVICE DESCRIPTION Agfa's DR 400 is a solid state x-ray system, a direct radiography (DR) system (product code MQB) i… | 2001 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K152639 | DR 600 | 2015 | 6 |
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 33 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- 14 of the 25 ancestors have a recall of any class.
- Of its descendants, K152639 (Agfa Healthcare N.V., 2015) has gone furthest, with 6 descendants of its own.
- 2 other devices also cite its predicate K122736.
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. 2014, 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?
The DR 400 system is a GenRad X-ray imaging system used in hospitals, clinics and medical practices by physicists, radiographers and radiologists to make, process and view static X-ray radiographic images of the skeleton (including skull, spinal column and extremities), chest, abdomen and other body parts on adult and pediatric patients. Applications can be performed with the patient in the sitting, standing or lying Position.
Agfa's DR 400 is not indicated for use in mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141192 · printed Nov 4, 2026
Cite this page
510(k) Report. “K141192: DR 400.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K141192
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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