510(k) · Cleared
ClearedAdc Compact Plus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agfa-Gevaert AG · MQB Solid State X-Ray Imager (Flat Panel/Digital Imager)
Cleared on Sep 28, 2001 as substantially equivalent to K974597 (Bayer Corp., Agfa Div., 1998) after a 9-day review. Its family tree reaches back 2 generations to 1991. 1 of the 434 devices in its family, counting itself, has a Class I recall. 431 later devices descend from it.
- Decided
- Sep 28, 2001
- Review
- 9 days
- Class
- Class II
- Product code
- MQB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K904519 (1991). 431 later devices descend from it, 4 citing it directly. 1 of the 434 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK904519 Agfa Diagnostic Center (Adc)Enhanced Imaging Technologies, Inc. · 1991
- 1 generation backK974597 Adc Compact (Agfa Diagnostic Center)Bayer Corp., Agfa Div. · 1998 · Recalled
- This deviceK013138 Adc Compact PlusAgfa-Gevaert AG · 2001
- Descendant · cites it directly · 413 of its ownK022881 Cedara I-SoftviewCedara Software Corp. · 2002 · Recalled
- Descendant · 2 generations on · 255 of its ownK040468 Cedara I-Softview and Cedara I-ReadmammoCedara Software Corp. · 2004 · Recalled
- Descendant · 3 generations on · 221 of its ownK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- Descendant · 4 generations on · 201 of its ownK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
- Descendant · 5 generations on · 200 of its ownK091373 Syngo TruedSiemens Medical Solutions USA, Inc. · 2009
Showing 5 of 431 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…10 generations on · 2025
Most influential descendants
Showing 5 of 431 · See all- K022881Cedara I-SoftviewCedara Software Corp. · 2002 · cites it directly413descendants
- K040468Cedara I-Softview and Cedara I-ReadmammoCedara Software Corp. · 2004 · 2 generations on255descendants
- K053301Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006 · 3 generations on221descendants
- K071950Syngo TruedSiemens Medical Solutions USA, Inc. · 2007 · 4 generations on201descendants
- K091373Syngo TruedSiemens Medical Solutions USA, Inc. · 2009 · 5 generations on200descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K904519 | Agfa Diagnostic Center (Adc) | Enhanced Imaging Technologies, Inc. | 1991 | — |
| −1 | K974597 | Adc Compact (Agfa Diagnostic Center) | Bayer Corp., Agfa Div. | 1998 | 1 |
| 0 (this device) | K013138 | Adc Compact Plus | Agfa-Gevaert AG | 2001 | — |
| +1 | K022881 | Cedara I-Softview | Cedara Software Corp. | 2002 | 3 |
| +2 | K040468 | Cedara I-Softview and Cedara I-Readmammo | Cedara Software Corp. | 2004 | 1 |
| +3 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| +4 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
| +5 | K091373 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 2 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 7 | 0 |
| 2008 | 5 | 0 |
| 2009 | 2 | 0 |
| 2010 | 7 | 0 |
| 2011 | 7 | 0 |
| 2012 | 9 | 0 |
| 2013 | 13 | 0 |
| 2014 | 14 | 0 |
| 2015 | 12 | 0 |
| 2016 | 19 | 0 |
| 2017 | 20 | 0 |
| 2018 | 28 | 0 |
| 2019 | 19 | 0 |
| 2020 | 35 | 0 |
| 2021 | 31 | 0 |
| 2022 | 32 | 0 |
| 2023 | 33 | 0 |
| 2024 | 34 | 0 |
| 2025 | 49 | 1 |
| 2026 | 46 | 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.
1 device in this family has a Class I recall. 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 |
|---|---|---|---|
| * | K974597 | Adc Compact (Agfa Diagnostic Center)Summary page 1…LEGALLY MARKETED PREDICATE DEVICES The predicate device is the previous version of the same device, namely the ADC Compact, which was cleared by FDA on 09 March 1998 as K974597. DEVICE DESCRIPTION The ADC Compact, the predicate device, is a computed radiology imaging system. Instead of screens and photo… | 1998 |
What descends from it? (431)
See all 4314 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K250443MAGNETOM Avanto Fit; MAGNETOM Skyra Fit; MAGNETOM Sola Fit; MAGNETOM Viato.MobileSiemens Healthcare GmbH · 2025 · 10 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 6.7 years on median.
- 1 of the 2 ancestors has a recall of any class.
- Of its descendants, K022881 (Cedara Software Corp., 2002) has gone furthest, with 413 descendants of its own.
- 3 other devices also cite its predicate K974597.
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 ADC Compact Plus is indicated for use to provide diagnostic quality images for aid in physician diagnosis. The ADC Compact Plus 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/K013138 · printed Nov 6, 2026
Cite this page
510(k) Report. “K013138: Adc Compact Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K013138
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026