510(k) · Cleared
ClearedDX-SI
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agfa Corp. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Nov 22, 2006 as substantially equivalent to K053634 (Agfa Corporation, 2006) and 2 other predicates after a 9-day review. Its family tree reaches back 2 generations to 1981. 6 later devices descend from it.
- Decided
- Nov 22, 2006
- Review
- 9 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K803130 (1981). 5 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 1 generation backK971452 Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997 · Recalled
- This deviceK063421 DX-SIAgfa Corp. · 2006
- Descendant · cites it directly · 5 of its ownK072010 Quantum Direx SystemQuantum Medical Imaging, LLC · 2007
- Descendant · 2 generations on · 4 of its ownK080905 Quantum/ Canon Cxdi Integration System, Model QG-Dig-CxdiQuantum Medical Imaging, LLC · 2008
- Descendant · 3 generations on · 3 of its ownK193574 Q-Rad SystemCarestream Health, Inc. · 2020
- Descendant · 4 generations on · 2 of its ownK201373 DRX-CompassCarestream Health, Inc. · 2020 · Recalled
- Descendant · 5 generations on · 1 of its ownK223842 DRX - CompassCarestream Health, Inc. · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K072010Quantum Direx SystemQuantum Medical Imaging, LLC · 2007 · cites it directly5descendants
- K080905Quantum/ Canon Cxdi Integration System, Model QG-Dig-CxdiQuantum Medical Imaging, LLC · 2008 · 2 generations on4descendants
- K193574Q-Rad SystemCarestream Health, Inc. · 2020 · 3 generations on3descendants
- K201373DRX-CompassCarestream Health, Inc. · 2020 · 4 generations on2descendants
- K223842DRX - CompassCarestream Health, Inc. · 2023 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K803130 | Multix U. Bucky Table X-Ray Unit | Siemens Corp. | 1981 | 1 |
| −1 | K971452 | Multix Top/Pro Radiographic X-Ray Table | Siemens Medical Solutions USA, Inc. | 1997 | 8 |
| 0 (this device) | K063421 | DX-SI | Agfa Corp. | 2006 | — |
| +1 | K072010 | Quantum Direx System | Quantum Medical Imaging, LLC | 2007 | — |
| +2 | K080905 | Quantum/ Canon Cxdi Integration System, Model QG-Dig-Cxdi | Quantum Medical Imaging, LLC | 2008 | — |
| +3 | K193574 | Q-Rad System | Carestream Health, Inc. | 2020 | — |
| +4 | K201373 | DRX-Compass | Carestream Health, Inc. | 2020 | 1 |
| +5 | K223842 | DRX - Compass | Carestream Health, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2020 | 2 | 0 |
| 2023 | 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? (3)
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…ed by Siemens Medical Solutions, AG. The predicate devices are Agfa's Computed Radiography System DX-S with NX workstation which was cleaned by FDA on January 17, 2006 (K053634) and Siemens Multix Top x-ray system (K971452, K010571), last cleared by FDA on March 28,2001 B. DEVICE DESCRIPTION The predica… | 2006 |
| * | K971452 | Multix Top/Pro Radiographic X-Ray TableSummary page 1…icate devices are Agfa's Computed Radiography System DX-S with NX workstation which was cleaned by FDA on January 17, 2006 (K053634) and Siemens Multix Top x-ray system (K971452, K010571), last cleared by FDA on March 28,2001 B. DEVICE DESCRIPTION The predicate and new devices are nearly identical comput… | 1997 |
| * | K010571 | Adc QS/Ipd WorkstationSummary page 1…ices are Agfa's Computed Radiography System DX-S with NX workstation which was cleaned by FDA on January 17, 2006 (K053634) and Siemens Multix Top x-ray system (K971452, K010571), last cleared by FDA on March 28,2001 B. DEVICE DESCRIPTION The predicate and new devices are nearly identical computed radiog… | 2001 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072010 | Quantum Direx System | 2007 | 5 |
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 25 years and passes through 3 companies; a new generation was cleared every 16.3 years on median.
- 4 of the 5 ancestors have a recall of any class.
- Of its descendants, K072010 (Quantum Medical Imaging, LLC, 2007) has gone furthest, with 5 descendants of its own.
- 2 other devices also cite its predicate K053634.
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 DX-Si system is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. The DX-Si can be used to perform radiographic exposures of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts. The DS-Xi Is not indicated for use in mammography.
Use with separately cleared accessories allows the DX-Si to be conveniently used in generating urological, tomographic, pediatric and dental images.
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/K063421 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063421: DX-SI.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063421
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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