510(k) · Cleared
ClearedDX-D 300
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agfa Healthcare N.V. · KPR System, X-Ray, Stationary
Cleared on Oct 29, 2010 as substantially equivalent to K092669 (Agfa Healthcare N.V., 2009) and 1 other predicate after a 14-day review. Its family tree reaches back 6 generations to 1981. 8 later devices descend from it.
- Decided
- Oct 29, 2010
- Review
- 14 days
- Class
- Class II
- Product code
- KPR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K803130 (1981). 25 ancestors in all. 8 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 5 generations backK971452 Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997 · Recalled
- 4 generations backK983732 Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- 3 generations backK992794 Stingray DR, Model 1Infimed, Inc. · 1999
- 2 generations backK024147 Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003
- 1 generation backK092669 DX-D Imaging PackageAgfa Healthcare N.V. · 2009 · Recalled
- This deviceK103050 DX-D 300Agfa Healthcare N.V. · 2010
- Descendant · cites it directly · 7 of its ownK112670 DX-D 600Agfa Healthcare N.V. · 2011 · Recalled
- Descendant · 2 generations on · 6 of its ownK152639 DR 600Agfa Healthcare N.V. · 2015
- Descendant · 3 generations on · 4 of its ownK193262 DR 600 with TomosynthesisAgfa N.V. · 2020
- Descendant · 4 generations on · 3 of its ownK222934 Nanox.ARCNano-X Imaging, Ltd. · 2023
- Descendant · 5 generations on · 2 of its ownK242395 Nanox.ARCNano-X Imaging, Ltd. · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K112670DX-D 600Agfa Healthcare N.V. · 2011 · cites it directly7descendants
- K152639DR 600Agfa Healthcare N.V. · 2015 · 2 generations on6descendants
- K193262DR 600 with TomosynthesisAgfa N.V. · 2020 · 3 generations on4descendants
- K222934Nanox.ARCNano-X Imaging, Ltd. · 2023 · 4 generations on3descendants
- K242395Nanox.ARCNano-X Imaging, Ltd. · 2024 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K803130 | Multix U. Bucky Table X-Ray Unit | Siemens Corp. | 1981 | 1 |
| −5 | K971452 | Multix Top/Pro Radiographic X-Ray Table | Siemens Medical Solutions USA, Inc. | 1997 | 8 |
| −4 | K983732 | Thorax FD and Multix FD | Siemens Medical Solutions USA, Inc. | 1999 | 1 |
| −3 | K992794 | Stingray DR, Model 1 | Infimed, Inc. | 1999 | — |
| −2 | K024147 | Paxscan 4030 Medical Digital Imaging System | Varian Medical Systems, Inc. | 2003 | — |
| −1 | K092669 | DX-D Imaging Package | Agfa Healthcare N.V. | 2009 | 1 |
| 0 (this device) | K103050 | DX-D 300 | Agfa Healthcare N.V. | 2010 | — |
| +1 | K112670 | DX-D 600 | Agfa Healthcare N.V. | 2011 | 4 |
| +2 | K152639 | DR 600 | Agfa Healthcare N.V. | 2015 | — |
| +3 | K193262 | DR 600 with Tomosynthesis | Agfa N.V. | 2020 | — |
| +4 | K222934 | Nanox.ARC | Nano-X Imaging, Ltd. | 2023 | — |
| +5 | K242395 | Nanox.ARC | Nano-X Imaging, Ltd. | 2024 | — |
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 | 2 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 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 KPR? 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 KPR device
- #1 K242119 Innovision-Exiiscore 17.0 · 9 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 |
|---|---|---|---|
| * | K092669 | DX-D Imaging PackageSummary page 1…9 A. LEGALLY MARKETED PREDICATE DEVICES This is a 5 10(k) for Agfia's flX-D 300, which is a combination of the two predicate devices: Agfa's OX-fl Imaging Package (K092669) and Sedecal's X Plus LP Plus x-ray system (K062335). B. DEVICE DESCRIPTION The device is a combination of a conventional x… | 2009 |
| * | K062335 | Sedecal X Plus LP PlusSummary page 1…s a 5 10(k) for Agfia's flX-D 300, which is a combination of the two predicate devices: Agfa's OX-fl Imaging Package (K092669) and Sedecal's X Plus LP Plus x-ray system (K062335). B. DEVICE DESCRIPTION The device is a combination of a conventional x-ray system with digital image capture equipment. Th… | 2006 |
| † | K051901 | NIO 3MP-21 | 2005 |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112670 | DX-D 600 | 2011 | 7 |
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 29 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, K112670 (Agfa Healthcare N.V., 2011) has gone furthest, with 7 descendants of its own.
- 3 other devices also cite its predicate K092669.
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · KPR
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPR
155in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPR
7in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPR
39in 2025
MAUDE reports naming product code KPR, 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 | 12 | 31 | 10 | 120 |
| 2008 | 15 | 48 | 10 | 95 |
| 2009 | 9 | 35 | 5 | 61 |
| 2010 | 9 | 126 | 3 | 82 |
| 2011 | 9 | 152 | 5 | 103 |
| 2012 | 11 | 58 | 1 | 74 |
| 2013 | 5 | 163 | 5 | 24 |
| 2014 | 10 | 108 | 8 | 34 |
| 2015 | 18 | 81 | 1 | 59 |
| 2016 | 11 | 84 | 4 | 18 |
| 2017 | 6 | 75 | 3 | 31 |
| 2018 | 15 | 30 | 4 | 36 |
| 2019 | 12 | 33 | 1 | 77 |
| 2020 | 16 | 39 | 1 | 41 |
| 2021 | 6 | 55 | 0 | 37 |
| 2022 | 8 | 43 | 2 | 27 |
| 2023 | 9 | 76 | 4 | 39 |
| 2024 | 11 | 162 | 1 | 34 |
| 2025 | 8 | 155 | 7 | 39 |
| 2026 | 6 | 197 | 0 | — |
What is it indicated for?
Agfa's DX-D 300 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis.
Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts.
Agfa's DX-D 300 is not indicated for use in mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103050 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103050: DX-D 300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103050
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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