510(k) · Cleared
Recalled · 2005Adc Compact (Agfa Diagnostic Center)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bayer Corp., Agfa Div. · KPR System, X-Ray, Stationary
Cleared on Mar 9, 1998 as substantially equivalent to K904519 (Enhanced Imaging Technologies, Inc., 1991) after a 90-day review. Its family tree reaches back 1 generation to 1991. 1 of the 438 devices in its family, counting itself, has a Class I recall. 436 later devices descend from it. It has been recalled once.
- Decided
- Mar 9, 1998
- Review
- 90 days
- Class
- Class II
- Product code
- KPR
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K904519 (1991). 436 later devices descend from it, 4 citing it directly. 1 of the 438 devices in this family, counting this one, has a Class I recall.
- Root · 1 generation backK904519 Agfa Diagnostic Center (Adc)Enhanced Imaging Technologies, Inc. · 1991
- This deviceK974597 Adc Compact (Agfa Diagnostic Center)Bayer Corp., Agfa Div. · 1998
- Descendant · cites it directly · 431 of its ownK013138 Adc Compact PlusAgfa-Gevaert AG · 2001
- Descendant · 2 generations on · 413 of its ownK022881 Cedara I-SoftviewCedara Software Corp. · 2002 · Recalled
- Descendant · 3 generations on · 255 of its ownK040468 Cedara I-Softview and Cedara I-ReadmammoCedara Software Corp. · 2004 · Recalled
- Descendant · 4 generations on · 221 of its ownK053301 Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006
- Descendant · 5 generations on · 201 of its ownK071950 Syngo TruedSiemens Medical Solutions USA, Inc. · 2007
Showing 5 of 436 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K250443 MAGNETOM Avanto Fit; MAGNETOM Skyra Fit…11 generations on · 2025
Most influential descendants
Showing 5 of 436 · See all- K013138Adc Compact PlusAgfa-Gevaert AG · 2001 · cites it directly431descendants
- K022881Cedara I-SoftviewCedara Software Corp. · 2002 · 2 generations on413descendants
- K040468Cedara I-Softview and Cedara I-ReadmammoCedara Software Corp. · 2004 · 3 generations on255descendants
- K053301Cedara I-Response Cedara Pet/CTCedara Software Corp. · 2006 · 4 generations on221descendants
- K071950Syngo TruedSiemens Medical Solutions USA, Inc. · 2007 · 5 generations on201descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K904519 | Agfa Diagnostic Center (Adc) | Enhanced Imaging Technologies, Inc. | 1991 | — |
| 0 (this device) | K974597 | Adc Compact (Agfa Diagnostic Center) | Bayer Corp., Agfa Div. | 1998 | — |
| +1 | K013138 | Adc Compact Plus | Agfa-Gevaert AG | 2001 | — |
| +2 | K022881 | Cedara I-Softview | Cedara Software Corp. | 2002 | 3 |
| +3 | K040468 | Cedara I-Softview and Cedara I-Readmammo | Cedara Software Corp. | 2004 | 1 |
| +4 | K053301 | Cedara I-Response Cedara Pet/CT | Cedara Software Corp. | 2006 | — |
| +5 | K071950 | Syngo Trued | Siemens Medical Solutions USA, Inc. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 4 | 0 |
| 2005 | 1 | 0 |
| 2006 | 4 | 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 KPR device
- #1 K242119 Innovision-Exiiscore 17.0 · 9 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 |
|---|---|---|---|
| * | K904519 | Agfa Diagnostic Center (Adc)Summary page 1…that reads and digitizes the imaging plates. The ADC COMPACT is substantially equivalent to the previous model produced by AGFA, the proprietary name being the ADC 70 (K904519A). It is also substantially equivalent to other computed radiography systems produced by other manufacturers and currently in com… | 1991 |
What descends from it? (436)
See all 4364 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 18, 2005 | Not classified | Z-0352-06 | Other | Users of affected systems may experience a loss of images, the need to repeat the imaging procedure and possibly a short delay in diagnosis. |
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 · 11 generations on · ◆ in the 2025 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
How does its category compare?
All KPR devicesKPR System, X-Ray, Stationary: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · KPR
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KPR
155in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KPR
7in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · KPR
39in 2025
MAUDE reports naming product code KPR, 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 | 12 | 31 | 10 | 120 |
| 2008 | 15 | 48 | 10 | 95 |
| 2009 | 9 | 35 | 5 | 61 |
| 2010 | 9 | 126 | 3 | 82 |
| 2011 | 9 | 152 | 5 | 103 |
| 2012 | 11 | 58 | 1 | 74 |
| 2013 | 5 | 163 | 5 | 24 |
| 2014 | 10 | 108 | 8 | 34 |
| 2015 | 18 | 81 | 1 | 59 |
| 2016 | 11 | 84 | 4 | 18 |
| 2017 | 6 | 75 | 3 | 31 |
| 2018 | 15 | 30 | 4 | 36 |
| 2019 | 12 | 33 | 1 | 77 |
| 2020 | 16 | 39 | 1 | 41 |
| 2021 | 6 | 55 | 0 | 37 |
| 2022 | 8 | 43 | 2 | 27 |
| 2023 | 9 | 76 | 4 | 39 |
| 2024 | 11 | 162 | 1 | 34 |
| 2025 | 8 | 155 | 7 | 39 |
| 2026 | 6 | 197 | 0 | — |
What is it indicated for?
To provide diagnostic quality images for aid in physician diagnosi‘s: Tt;is is used in the X-Ray imaging modality, mainly in Chest, Skeleton, and Gastro-Intestinal 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/K974597 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974597: Adc Compact (Agfa Diagnostic Center).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974597
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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