510(k) · Cleared
ClearedDAR-2400-15B/30B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shimadzu Medical Systems · IZI System, X-Ray, Angiographic
Cleared on Dec 11, 1995 after a 17-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 4 later devices descend from it.
- Decided
- Dec 11, 1995
- Review
- 17 days
- Class
- Class II
- Product code
- IZI
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 4 citing it directly.
- This deviceK955395 DAR-2400-15B/30BShimadzu Medical Systems · 1995
- Descendant · cites it directly · 0 of its ownK071717 GE Oec AltitudeShimadzu Corp. · 2007
- Descendant · cites it directly · 0 of its ownK052039 GE Oec AltitudeGe Oec Medical Systems · 2005
- Descendant · cites it directly · 0 of its ownK032443 Digital Angiography System Digitex SafireShimadzu Corp. · 2004
- Descendant · cites it directly · 0 of its ownK973342 DAR-3000BShimadzu Corp. · 1997
Most influential descendants
Showing 4 of 4 · See all- K071717GE Oec AltitudeShimadzu Corp. · 2007 · cites it directly0descendants
- K052039GE Oec AltitudeGe Oec Medical Systems · 2005 · cites it directly0descendants
- K032443Digital Angiography System Digitex SafireShimadzu Corp. · 2004 · cites it directly0descendants
- K973342DAR-3000BShimadzu Corp. · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K955395 | DAR-2400-15B/30B | Shimadzu Medical Systems | 1995 | — |
| +1 | K071717 | GE Oec Altitude | Shimadzu Corp. | 2007 | — |
| +1 | K052039 | GE Oec Altitude | Ge Oec Medical Systems | 2005 | — |
| +1 | K032443 | Digital Angiography System Digitex Safire | Shimadzu Corp. | 2004 | — |
| +1 | K973342 | DAR-3000B | Shimadzu Corp. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (4)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K071717 (Shimadzu Corp., 2007) has gone furthest, with 0 descendants of its own.
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 | — |
https://510kreport.com/device/K955395 · printed Nov 6, 2026
Cite this page
510(k) Report. “K955395: DAR-2400-15B/30B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K955395
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026