510(k) · Cleared
ClearedAfga CR25.0 Computed Radiography System
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 Jul 22, 2004 as substantially equivalent to K013138 (Agfa-Gevaert AG, 2001) after a 30-day review. Its family tree reaches back 3 generations to 1991. 12 later devices descend from it.
- Decided
- Jul 22, 2004
- Review
- 30 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K904519 (1991). 12 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK904519 Agfa Diagnostic Center (Adc)Enhanced Imaging Technologies, Inc. · 1991
- 2 generations backK974597 Adc Compact (Agfa Diagnostic Center)Bayer Corp., Agfa Div. · 1998 · Recalled
- 1 generation backK013138 Adc Compact PlusAgfa-Gevaert AG · 2001
- This deviceK041701 Afga CR25.0 Computed Radiography SystemAgfa Corp. · 2004
- Descendant · cites it directly · 8 of its ownK062223 Agfa Model CR30-XAgfa Corporation · 2006
- Descendant · 2 generations on · 5 of its ownK072010 Quantum Direx SystemQuantum Medical Imaging, LLC · 2007
- Descendant · 3 generations on · 4 of its ownK080905 Quantum/ Canon Cxdi Integration System, Model QG-Dig-CxdiQuantum Medical Imaging, LLC · 2008
- Descendant · 4 generations on · 3 of its ownK193574 Q-Rad SystemCarestream Health, Inc. · 2020
- Descendant · 5 generations on · 2 of its ownK201373 DRX-CompassCarestream Health, Inc. · 2020 · Recalled
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K062223Agfa Model CR30-XAgfa Corporation · 2006 · cites it directly8descendants
- K072010Quantum Direx SystemQuantum Medical Imaging, LLC · 2007 · 2 generations on5descendants
- K080905Quantum/ Canon Cxdi Integration System, Model QG-Dig-CxdiQuantum Medical Imaging, LLC · 2008 · 3 generations on4descendants
- K193574Q-Rad SystemCarestream Health, Inc. · 2020 · 4 generations on3descendants
- K201373DRX-CompassCarestream Health, Inc. · 2020 · 5 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K904519 | Agfa Diagnostic Center (Adc) | Enhanced Imaging Technologies, Inc. | 1991 | — |
| −2 | K974597 | Adc Compact (Agfa Diagnostic Center) | Bayer Corp., Agfa Div. | 1998 | 1 |
| −1 | K013138 | Adc Compact Plus | Agfa-Gevaert AG | 2001 | — |
| 0 (this device) | K041701 | Afga CR25.0 Computed Radiography System | Agfa Corp. | 2004 | — |
| +1 | K062223 | Agfa Model CR30-X | Agfa Corporation | 2006 | — |
| +2 | K072010 | Quantum Direx System | Quantum Medical Imaging, LLC | 2007 | — |
| +3 | K080905 | Quantum/ Canon Cxdi Integration System, Model QG-Dig-Cxdi | Quantum Medical Imaging, LLC | 2008 | — |
| +4 | K193574 | Q-Rad System | Carestream Health, Inc. | 2020 | — |
| +5 | K201373 | DRX-Compass | Carestream Health, Inc. | 2020 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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? (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 |
|---|---|---|---|
| * | K013138 | Adc Compact PlusSummary page 1…Madification. The predicate device is the device that was modified to produce the CR25.0, namely the ADC Compact Plus, which was cleared by FDA on. 28 September 2001 as K013138. B. DEVICE DESCRIPTION The ADC Compact Plus, the predicate device, is a computed radiology imaging system. Instead of screens a… | 2001 |
What descends from it? (12)
See all 123 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?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K062223 (Agfa Corporation, 2006) has gone furthest, with 8 descendants of its own.
- 3 other devices also cite its predicate K013138.
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?
The CR25.0 is indicated for use to provide diagnostic quality images to aid in physician diagnosis. The CR25.0 is intended to be used mainly in chest, skeletal, and gastro-intestinal x-ray imaging applications.
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/K041701 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041701: Afga CR25.0 Computed Radiography System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041701
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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