510(k) · Cleared
ClearedFuji IP Cassette Type PC
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fujifilm Medical Systems U.S.A, Inc. · IYE Accelerator, Linear, Medical
Cleared on May 22, 2007 as substantially equivalent to K042779 (Agfa Corp., 2004) and 1 other predicate after a 50-day review. Its family tree reaches back 5 generations to 1991.
- Decided
- May 22, 2007
- Review
- 50 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K904519 (1991). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK904519 Agfa Diagnostic Center (Adc)Enhanced Imaging Technologies, Inc. · 1991
- 4 generations backK974597 Adc Compact (Agfa Diagnostic Center)Bayer Corp., Agfa Div. · 1998 · Recalled
- 3 generations backK013138 Adc Compact PlusAgfa-Gevaert AG · 2001
- 2 generations backK041701 Afga CR25.0 Computed Radiography SystemAgfa Corp. · 2004
- 1 generation backK042779 Radiotherapy Solution Based on CRAgfa Corp. · 2004
- This deviceK070920 Fuji IP Cassette Type PCFujifilm Medical Systems U.S.A, Inc. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K904519 | Agfa Diagnostic Center (Adc) | Enhanced Imaging Technologies, Inc. | 1991 | — |
| −4 | K974597 | Adc Compact (Agfa Diagnostic Center) | Bayer Corp., Agfa Div. | 1998 | 1 |
| −3 | K013138 | Adc Compact Plus | Agfa-Gevaert AG | 2001 | — |
| −2 | K041701 | Afga CR25.0 Computed Radiography System | Agfa Corp. | 2004 | — |
| −1 | K042779 | Radiotherapy Solution Based on CR | Agfa Corp. | 2004 | — |
| 0 (this device) | 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 |
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 IYE? 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 IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K042779 | Radiotherapy Solution Based on CR | 2004 |
| * | K960834 | Kodak EC-L CassetteSummary page 1…Agfa CR RTIL. Low Dose Cassette K042'779 Kodak EC-L Film Cassette K960834 Description of the Device The Fuji IP Cassette Type PC will be used as an accessory to medical charged particle radiation thera… | 1996 |
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 16 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 7 ancestors has a recall of any class.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, 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 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
The Fuji IP Cassette Type PC will be used as an accessory to megavoltage radiation therapy systems providing radiation therapy portal localization imaging and to aid in radiation therapy planning and quality control.
The Fuji IP Cassette Type PC and imaging plate is a digital replacement technology for conventional film/cassette imaging systems.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070920 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070920: Fuji IP Cassette Type PC.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070920
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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