510(k) · Cleared
ClearedRadiotherapy Solution Based on CR
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Agfa Corp. · IXK System, Imaging, X-Ray, Electrostatic
Cleared on Oct 21, 2004 as substantially equivalent to K032654 (Orex Computed Radiography, Ltd., 2003) and 1 other predicate after a 15-day review. Its family tree reaches back 4 generations to 1991. 1 later device descends from it.
- Decided
- Oct 21, 2004
- Review
- 15 days
- Class
- Class II
- Product code
- IXK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K904519 (1991). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- 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 backK041701 Afga CR25.0 Computed Radiography SystemAgfa Corp. · 2004
- This deviceK042779 Radiotherapy Solution Based on CRAgfa Corp. · 2004
- Descendant · cites it directly · 0 of its ownK070920 Fuji IP Cassette Type PCFujifilm Medical Systems U.S.A, Inc. · 2007
Most influential descendants
Showing 1 of 1 · See all- K070920Fuji IP Cassette Type PCFujifilm Medical Systems U.S.A, Inc. · 2007 · cites it directly0descendants
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 | K041701 | Afga CR25.0 Computed Radiography System | Agfa Corp. | 2004 | — |
| 0 (this device) | K042779 | Radiotherapy Solution Based on CR | Agfa Corp. | 2004 | — |
| +1 | K070920 | Fuji IP Cassette Type PC | Fujifilm Medical Systems U.S.A, Inc. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 IXK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K032654 | Port CassetteSummary page 1…Prepared: August 9, 2004 A. LEGALLY MARKETED (PREDICATE) DEVICES The Radiotherapy Solution Based on CR is substantially equivalent to the PoRT Cassette (K032654) in regard to its indications for use and cassette characteristics, and to the CR25.0 in regard to the image acquisition an… | 2003 |
| * | K041701 | Afga CR25.0 Computed Radiography SystemSummary page 1…2654) in regard to its indications for use and cassette characteristics, and to the CR25.0 in regard to the image acquisition and processing characteristics (K041701). The Radiotherapy Solution Based on CR should be considered as an accessory to the CR25.0, as was the case for the P… | 2004 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070920 | Fuji IP Cassette Type PC | 2007 | 0 |
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 13 years and passes through 4 companies; a new generation was cleared every 3.6 years on median.
- 1 of the 6 ancestors has a recall of any class.
- Of its descendants, K070920 (Fujifilm Medical Systems U.S.A, Inc., 2007) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K032654.
How does its category compare?
All IXK devicesIXK System, Imaging, X-Ray, Electrostatic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IXK
1in 2011
2026 to Oct 25, outlined.
Median 510(k) review, days · IXK
Too few IXK 510(k)s in any year since 2007 to give a median.
Recalls per year · IXK
No recall names IXK since 2007.
Adverse event reports per year · IXK
No MAUDE report names IXK since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Radiotherapy Solution Based on CR25.0 is indicated for producing simulation and
verification (portal) radiotherapy images to aid in radiation therapy planning and quality
control.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042779 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042779: Radiotherapy Solution Based on CR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042779
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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