510(k) · Cleared
ClearedDigital Radiography System with Flat Panel Detector, Model DFP8000D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Toshibamedical Systems Corporation · IZI System, X-Ray, Angiographic
Cleared on May 14, 2004 as substantially equivalent to K013608 (Toshiba America Medical Systems, In.C, 2001) and 1 other predicate after a 23-day review. Its family tree reaches back 2 generations to 1977.
- Decided
- May 14, 2004
- Review
- 23 days
- Class
- Class II
- Product code
- IZI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K771298 (1977). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 2 generations backK771298 6 L.L. SystemToshiba Medical Systems · 1977
- 1 generation backK993038 Toshiba RTP9211J-G11, J-Advanced Image Intensifier (I.I.)Toshiba America Medical Systems, In.C · 1999
- This deviceK041027 Digital Radiography System with Flat Panel Detector, Model DFP8000DToshibamedical Systems Corporation · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K771298 | 6 L.L. System | Toshiba Medical Systems | 1977 | — |
| −1 | K993038 | Toshiba RTP9211J-G11, J-Advanced Image Intensifier (I.I.) | Toshiba America Medical Systems, In.C | 1999 | — |
| 0 (this device) | K041027 | Digital Radiography System with Flat Panel Detector, Model DFP8000D | Toshibamedical Systems Corporation | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2001 | 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 IZI? 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 IZI device
- #1 K230727 SPY Portable Handheld Imaging (SPY-PHI) Systemscore 23.2 · 20 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 |
|---|---|---|---|
| * | K013608 | Digital Radiography System, Model DFP-8000DSummary page 1…Site: TOSHIBA MEDICAL SYSTEMS CORPORATION ' 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan 5. Date of Submission: April 08, 2004 6. Predicate Device: DFP-8000D (K013608) with Image Intensifier (K993038) 7. DEVICE DESCRIPTION This equipment is a digital radiography with Flat Panel Detector (FPD) u… | 2001 |
| * | K993038 | Toshiba RTP9211J-G11, J-Advanced Image Intensifier (I.I.)Summary page 1…PORATION ' 1385 Shimoishigami Otawara-shi, Tochigi 324-8550, Japan 5. Date of Submission: April 08, 2004 6. Predicate Device: DFP-8000D (K013608) with Image Intensifier (K993038) 7. DEVICE DESCRIPTION This equipment is a digital radiography with Flat Panel Detector (FPD) used in diagnostic X-ray angiograp… | 1999 |
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 27 years and passes through 3 companies; a new generation was cleared every 22.2 years on median.
- 2 of the 4 ancestors have a recall of any class.
- 1 other device also cites its predicate K013608.
How does its category compare?
All IZI devicesIZI System, X-Ray, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IZI
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IZI
81in 2023
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZI
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZI
2,171in 2025
MAUDE reports naming product code IZI, 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 | 7 | 28 | 6 | 92 |
| 2008 | 6 | 68 | 52 | 101 |
| 2009 | 2 | — | 18 | 132 |
| 2010 | 2 | — | 11 | 252 |
| 2011 | 4 | 104 | 6 | 377 |
| 2012 | 1 | — | 6 | 77 |
| 2013 | 1 | — | 6 | 58 |
| 2014 | 4 | 111 | 5 | 123 |
| 2015 | 0 | — | 14 | 36 |
| 2016 | 1 | — | 7 | 102 |
| 2017 | 2 | — | 1 | 88 |
| 2018 | 2 | — | 2 | 49 |
| 2019 | 2 | — | 2 | 30 |
| 2020 | 1 | — | 2 | 14 |
| 2021 | 1 | — | 1 | 29 |
| 2022 | 1 | — | 0 | 265 |
| 2023 | 3 | 81 | 0 | 1,204 |
| 2024 | 2 | — | 0 | 1,332 |
| 2025 | 2 | — | 0 | 2,171 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
This device is a digital radiography system used in diagnostic X-ray angiography system configuration.
This X-ray angiography system is indicated for use in diagnostic and interventional cardiac examinations.
It is intended to replace images obtained through the image intensifier technology.
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/K041027 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041027: Digital Radiography System with Flat Panel Detector, Model DFP8000D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041027
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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