510(k) · Cleared
ClearedDAR-3000B
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Shimadzu Corp. · IZI System, X-Ray, Angiographic
Cleared on Oct 8, 1997 as substantially equivalent to K920720 (Shimadzu Medical Systems, 1992) and 1 other predicate after a 33-day review. Its family tree reaches back 1 generation to 1992.
- Decided
- Oct 8, 1997
- Review
- 33 days
- Class
- Class II
- Product code
- IZI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K920720 (1992). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK920720 Digital Radiography System Idr-1000Shimadzu Medical Systems · 1992
- This deviceK973342 DAR-3000BShimadzu Corp. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K920720 | Digital Radiography System Idr-1000 | Shimadzu Medical Systems | 1992 | — |
| 0 (this device) | K973342 | DAR-3000B | Shimadzu Corp. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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 |
|---|---|---|---|
| * | K920720 | Digital Radiography System Idr-1000Summary page 2…tal patient populations. As mentioned at “Intended Use” in this clearance letter, the intended use of ] the DAR-3000B is the same as that of predicate device IDR-1000 (K920720) and DAR-2400-15B/30B (K955395). Consequently, the indications for use of the DAR-3000B are also the same as ( that of the IDR-… | 1992 |
| * | K955395 | DAR-2400-15B/30BSummary page 2…ntioned at “Intended Use” in this clearance letter, the intended use of ] the DAR-3000B is the same as that of predicate device IDR-1000 (K920720) and DAR-2400-15B/30B (K955395). Consequently, the indications for use of the DAR-3000B are also the same as ( that of the IDR-1000 (K920720) and DAR-2400-15B… | 1995 |
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?
- None of the 2 ancestors has a recall.
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 intended to be used in Angiography in Hospital with the X-ray devices.
This device is operated and used by Physicians and X-ray technologist.
The object of this device is total patient populations.
As mentioned at “Intended Use” in this clearance letter, the intended use of the DAR-3000B is the same as that of predicate device IDR-1000 (K920720) and DAR-2400-15B/30B (K955395).
Consequently, the indications for use of the DAR-3000B are also the same as that of the IDR-1000 (K920720) and DAR-2400-15B/30B (K955395), and there are no additional indications.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K973342 · printed Nov 6, 2026
Cite this page
510(k) Report. “K973342: DAR-3000B.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973342
Report an extraction error
Are you the manufacturer?
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