510(k) · Cleared
Recalled · Class II · 2013CR 10-X Digitizer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agfa Healthcare N.V. · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Jul 20, 2012 as substantially equivalent to K062223 (Agfa Corporation, 2006) after a 17-day review. Its family tree reaches back 5 generations to 1991. 1 later device descends from it. It has been recalled once.
- Decided
- Jul 20, 2012
- Review
- 17 days
- Class
- Class II
- Product code
- MQB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 5 generations to K904519 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK904519 Agfa Diagnostic Center (Adc)Enhanced Imaging Technologies, Inc. · 1991
- 4 generations backK974597 Adc Compact (Agfa Diagnostic Center)Bayer Corp., Agfa Div. · 1998 · Recalled
- 3 generations backK013138 Adc Compact PlusAgfa-Gevaert AG · 2001
- 2 generations backK041701 Afga CR25.0 Computed Radiography SystemAgfa Corp. · 2004
- 1 generation backK062223 Agfa Model CR30-XAgfa Corporation · 2006
- This deviceK121948 CR 10-X DigitizerAgfa Healthcare N.V. · 2012
- Descendant · cites it directly · 0 of its ownK131408 CR 12-X DigitizerAgfa Healthcare N.V. · 2013
Most influential descendants
Showing 1 of 1 · See all- K131408CR 12-X DigitizerAgfa Healthcare N.V. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K904519 | Agfa Diagnostic Center (Adc) | Enhanced Imaging Technologies, Inc. | 1991 | — |
| −4 | K974597 | Adc Compact (Agfa Diagnostic Center) | Bayer Corp., Agfa Div. | 1998 | 1 |
| −3 | K013138 | Adc Compact Plus | Agfa-Gevaert AG | 2001 | — |
| −2 | K041701 | Afga CR25.0 Computed Radiography System | Agfa Corp. | 2004 | — |
| −1 | K062223 | Agfa Model CR30-X | Agfa Corporation | 2006 | — |
| 0 (this device) | K121948 | CR 10-X Digitizer | Agfa Healthcare N.V. | 2012 | — |
| +1 | K131408 | CR 12-X Digitizer | Agfa Healthcare N.V. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 |
|---|---|---|---|
| * | K062223 | Agfa Model CR30-XSummary page 1…a's Computed Radiography (CR) System with CR 10-X Digitizer, a solid state x-ray imaging device. It is substantially equivalent to systems with Agfa's CR 30-X digitizer (K062223). B. DEVICE DESCRIPTION Agfa's Computed Radiography (CR) Systems with CR l0-X Digitizer is asolid state x-ray imaging devi… | 2006 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131408 | CR 12-X Digitizer | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 7, 2013 | Class II | Z-0970-2013 | Nonconforming Material/Component | The cassettes were shipped with the wrong IP (image plate) size bar code. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 21 years and passes through 6 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K131408 (Agfa Healthcare N.V., 2013) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K062223.
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. 2012, this device’s year, is highlighted.
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 Computed Radiography (CR) System with CR 10-X Digitizer is indicated for use in general projection radiographic applications to capture for display diagnostic quality radiographic images of human anatomy. The system may be used wherever conventional screen-film systems are used.
Agfa's Computed Radiography (CR) System With CR 10-X Digitizer is not indicated for use in mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K121948 · printed Nov 6, 2026
Cite this page
510(k) Report. “K121948: CR 10-X Digitizer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K121948
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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