510(k) · Cleared
ClearedComputed Radiography 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 Jan 15, 2014 as substantially equivalent to K102619 (3Disc Americas, 2011) after a 107-day review. Its family tree reaches back 4 generations to 1991.
- Decided
- Jan 15, 2014
- Review
- 107 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- 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 backK102619 Computed Raddiography Scanner3Disc Americas · 2011
- This deviceK133106 Computed Radiography Scanner3Disc Americas · 2014
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 | K102619 | Computed Raddiography Scanner | 3Disc Americas | 2011 | — |
| 0 (this device) | K133106 | Computed Radiography Scanner | 3Disc Americas | 2014 | — |
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 |
|---|---|---|---|
| * | K102619 | Computed Raddiography ScannerSummary page 1…tem 3. Predicate Device: Manufacturer: 3D Imaging & Simulations Corp. Device: FireCR 510(k) Number: K102619 (Decision Date -Mar. 1. 2011) 4. Classifications Names & Citations 21 CFR 892.1680, MQB - Stationary x-ray system, Class… | 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 23 years and passes through 4 companies; a new generation was cleared every 6.7 years on median.
- 1 of the 4 ancestors has a recall of any class.
- 2 other devices also cite its predicate K102619.
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. 2014, 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 isa 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 (IP3) and workstation software. It scans X-Ray exposed image plate and produces X-Ray image indigital form. Then, digital image is transferred to workstation for further processing and routing. This device is intended to be operated ina radiological environment by qualified staff. This device is not intended for the acquisition of mammographic image data.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133106 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133106: Computed Radiography Scanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133106
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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