510(k) · Cleared
ClearedComputed Raddiography Scanner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3Disc Americas · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on May 13, 2011 as substantially equivalent to K013138 (Agfa-Gevaert AG, 2001) after a 242-day review. Its family tree reaches back 3 generations to 1991. 3 later devices descend from it.
- Decided
- May 13, 2011
- Review
- 242 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K904519 (1991). 3 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 deviceK102619 Computed Raddiography Scanner3Disc Americas · 2011
- Descendant · cites it directly · 0 of its ownK133106 Computed Radiography Scanner3Disc Americas · 2014
- Descendant · cites it directly · 0 of its ownK133120 Computed Radiography Scanner3Disc Americas · 2014
- Descendant · cites it directly · 0 of its ownK131408 CR 12-X DigitizerAgfa Healthcare N.V. · 2013
Most influential descendants
Showing 3 of 3 · See allView 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) | K102619 | Computed Raddiography Scanner | 3Disc Americas | 2011 | — |
| +1 | K133106 | Computed Radiography Scanner | 3Disc Americas | 2014 | — |
| +1 | K133120 | Computed Radiography Scanner | 3Disc Americas | 2014 | — |
| +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 |
| 2014 | 2 | 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…ography Scanner Classification Name : Solid-State X-ray Imaging system 3. Predicate Devices : Manufacturer : AGFA Corporation Device : ADC Compact Plus 510(k) Number : K013138(Decision Date - Sep. 28. 2001) 4. Classifications Names & Citations : 21CFR 892.1650, MQB - Solid-State X-ray Imaging system, Cl… | 2001 |
What descends from it? (3)
3 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 20 years and passes through 4 companies; a new generation was cleared every 6.7 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K133106 (3Disc Americas, 2014) has gone furthest, with 0 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. 2011, 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?
This device is a Computed Radiography System and intended for use in producing digital X-Ray images for general radiography purposes. It comprises of scanner, cassette with reusable phosphor storage plate (IP) and workstation software. It scans X-Ray exposed image plate and produces X-Ray image in digital form. Then, digital image is transferred to workstation for further processing and routing. This device is intended to be operated in a radiological environment by qualified staff.
This device is not intended for the acquisition of mammographic image data.
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/K102619 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102619: Computed Raddiography Scanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102619
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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