510(k) · Cleared
ClearedCR 12-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 Aug 29, 2013 as substantially equivalent to K121948 (Agfa Healthcare N.V., 2012) and 1 other predicate after a 106-day review. Its family tree reaches back 6 generations to 1991.
- Decided
- Aug 29, 2013
- Review
- 106 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K904519 (1991). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK904519 Agfa Diagnostic Center (Adc)Enhanced Imaging Technologies, Inc. · 1991
- 5 generations backK974597 Adc Compact (Agfa Diagnostic Center)Bayer Corp., Agfa Div. · 1998 · Recalled
- 4 generations backK013138 Adc Compact PlusAgfa-Gevaert AG · 2001
- 3 generations backK041701 Afga CR25.0 Computed Radiography SystemAgfa Corp. · 2004
- 2 generations backK062223 Agfa Model CR30-XAgfa Corporation · 2006
- 1 generation backK121948 CR 10-X DigitizerAgfa Healthcare N.V. · 2012 · Recalled
- This deviceK131408 CR 12-X DigitizerAgfa Healthcare N.V. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K904519 | Agfa Diagnostic Center (Adc) | Enhanced Imaging Technologies, Inc. | 1991 | — |
| −5 | K974597 | Adc Compact (Agfa Diagnostic Center) | Bayer Corp., Agfa Div. | 1998 | 1 |
| −4 | K013138 | Adc Compact Plus | Agfa-Gevaert AG | 2001 | — |
| −3 | K041701 | Afga CR25.0 Computed Radiography System | Agfa Corp. | 2004 | — |
| −2 | K062223 | Agfa Model CR30-X | Agfa Corporation | 2006 | — |
| −1 | K121948 | CR 10-X Digitizer | Agfa Healthcare N.V. | 2012 | 1 |
| 0 (this device) | K131408 | CR 12-X Digitizer | Agfa Healthcare N.V. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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? (2)
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 |
|---|---|---|---|
| * | K121948 | CR 10-X DigitizerSummary page 1…'s Computed Radiography (CR) System with CR I 2-X Digitizer, a solid state x-ray imaging device, It is substantially equivalent to systems with Agfa's CR I0-X Digitizer (K 121948) and 3Disc America's Fire CR± Digitizer (K10261 9). B. DEVICE DESCRIPTION Agfa's Computed Radiography (CR) Systems with CR… | 2012 |
| * | K102619 | Computed Raddiography ScannerSummary page 1…Digitizer, a solid state x-ray imaging device, It is substantially equivalent to systems with Agfa's CR I0-X Digitizer (K 121948) and 3Disc America's Fire CR± Digitizer (K10261 9). B. DEVICE DESCRIPTION Agfa's Computed Radiography (CR) Systems with CR 12-X Digitizer is a solid state x-ray imaging devi… | 2011 |
What descends from it?
No later submission names this one as a predicate yet.
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 22 years and passes through 6 companies; a new generation was cleared every 3.6 years on median.
- 2 of the 7 ancestors have a recall of any class.
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. 2013, 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 12-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 12-X Digitizer is not indicated for use in mammography.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131408 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131408: CR 12-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/K131408
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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