510(k) · Cleared
ClearedAgfa Model CR30-X
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agfa Corporation · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Sep 1, 2006 as substantially equivalent to K041701 (Agfa Corp., 2004) after a 30-day review. Its family tree reaches back 4 generations to 1991. 8 later devices descend from it.
- Decided
- Sep 1, 2006
- Review
- 30 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K904519 (1991). 8 later devices descend from it, 2 citing it directly.
- 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 deviceK062223 Agfa Model CR30-XAgfa Corporation · 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 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · 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 |
|---|---|---|---|---|---|
| −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) | K062223 | Agfa Model CR30-X | Agfa Corporation | 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 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 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 |
|---|---|---|---|
| * | K041701 | Afga CR25.0 Computed Radiography SystemSummary page 1…is is a Special 510(k) for a device modification. The modified device is Agfa's CR30-X. The predicate device is Agfa's CR25.0 which was cleared by FDA on July 22, 2004 (K041701). B. DEVICE DESCRIPTION The predicate and newly modified devices are computed radiography imaging systems. Instead of tradition… | 2004 |
What descends from it? (8)
2 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 15 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 4 ancestors has 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 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 CR30-X is indicated for use to provide diagnostic quality images to aid in physician diagnosis. The CR30-X 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/K062223 · printed Nov 5, 2026
Cite this page
510(k) Report. “K062223: Agfa Model CR30-X.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K062223
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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