510(k) · Cleared
Recalled · 2006Agfa CR50.0
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 Apr 21, 2005 as substantially equivalent to K041701 (Agfa Corp., 2004) after a 21-day review. Its family tree reaches back 4 generations to 1991. It has been recalled 2 times.
- Decided
- Apr 21, 2005
- Review
- 21 days
- Class
- Class II
- Product code
- MQB
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 4 generations to K904519 (1991). No later device cites it as a predicate yet.
- Root · 4 generations backK904519 Agfa Diagnostic Center (Adc)Enhanced Imaging Technologies, Inc. · 1991
- 3 generations backK974597 Adc Compact (Agfa Diagnostic Center)Bayer Corp., Agfa Div. · 1998 · Recalled
- 2 generations backK013138 Adc Compact PlusAgfa-Gevaert AG · 2001
- 1 generation backK041701 Afga CR25.0 Computed Radiography SystemAgfa Corp. · 2004
- This deviceK050810 Agfa CR50.0Agfa Corp. · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K904519 | Agfa Diagnostic Center (Adc) | Enhanced Imaging Technologies, Inc. | 1991 | — |
| −3 | K974597 | Adc Compact (Agfa Diagnostic Center) | Bayer Corp., Agfa Div. | 1998 | 1 |
| −2 | K013138 | Adc Compact Plus | Agfa-Gevaert AG | 2001 | — |
| −1 | K041701 | Afga CR25.0 Computed Radiography System | Agfa Corp. | 2004 | — |
| 0 (this device) | K050810 | Agfa CR50.0 | Agfa Corp. | 2005 | — |
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 |
|---|---|---|---|
| * | K041701 | Afga CR25.0 Computed Radiography SystemSummary page 1…10(k) for Device Modification. The predicate device is the device that was modifted to produce the CR50.0, namely the CR25.0, which was cleared by FDA on 22 July 2004 as K041701. B. DEVICE DESCRIPTION The CR50.0, the predicate device, is a computed radiology imaging system. Instead of screens and photogr… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 28, 2006 | Not classified | Z-0031-2007 | Other | Three separate issues involving the Agfa DX-S CR System, were detected that could lead to an image loss. |
| Nov 3, 2005 | Not classified | Z-0855-06 | Other | Corrupted image after system start; Corrupted image after workflow interruption; An erasure unit problem can cause system to stop. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 14 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 2 other devices also cite its predicate K041701.
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 CR50.0 is indicated for use to provide diagnostic quality images to aid in physician diagnosis. The CR50.0 is intended to be used mainly in chest, skeletal and gastro-intestinal 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/K050810 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050810: Agfa CR50.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050810
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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