510(k) · Cleared

Recalled · Class II · 2018

DAR-8000F

K052500510(k) AbbreviatedCleared Oct 17, 200534-day reviewClass II21 CFR 892.1600Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Shimadzu Medical Systems · IZI System, X-Ray, Angiographic

Cleared on Oct 17, 2005 as substantially equivalent to K050925 (Shimadzu Corp., 2005) after a 34-day review. Its family tree reaches back 1 generation to 2005. 8 later devices descend from it. It has been recalled 2 times.

Decided: Oct 17, 2005
Review: 34 days
Class: Class II
Product code: IZI
Recalls: 2
Predicates: 1

Its longest line of descent runs back 1 generation to K050925 (2005). 8 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK050925 Digital Radiography System Radspeed SafireShimadzu Corp. · 2005
This deviceK052500 DAR-8000FShimadzu Medical Systems · 2005
Descendant · cites it directly · 6 of its ownK131075 X-Ray TV System Sonial Vision G4Shimadzu Corp. · 2014
Descendant · 2 generations on · 5 of its ownK142341 X-Ray TV System Sonialvision G4Shimadzu Corp. · 2015 · Recalled
Descendant · 3 generations on · 4 of its ownK190373 SonialVision G4Shimadzu Corporation · 2019 · Recalled
Descendant · 4 generations on · 1 of its ownK212212 Multitom Rax with True2scale Body Scan OptionSiemens Medical Solutions · 2022
Descendant · 5 generations on · 0 of its ownK221281 Multitom RaxSiemens Medical Solutions · 2022 · Recalled

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2007high 2 (2019) · low 0 (2008)2026

Most influential descendants

Showing 5 of 8 · See all

K131075X-Ray TV System Sonial Vision G4Shimadzu Corp. · 2014 · cites it directly6descendants
K142341X-Ray TV System Sonialvision G4Shimadzu Corp. · 2015 · 2 generations on5descendants
K190373SonialVision G4Shimadzu Corporation · 2019 · 3 generations on4descendants
K212212Multitom Rax with True2scale Body Scan OptionSiemens Medical Solutions · 2022 · 4 generations on1descendant
K221281Multitom RaxSiemens Medical Solutions · 2022 · 5 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K050925	Digital Radiography System Radspeed Safire	Shimadzu Corp.	2005	—
0 (this device)	K052500	DAR-8000F	Shimadzu Medical Systems	2005	—
+1	K131075	X-Ray TV System Sonial Vision G4	Shimadzu Corp.	2014	—
+2	K142341	X-Ray TV System Sonialvision G4	Shimadzu Corp.	2015	2
+3	K190373	SonialVision G4	Shimadzu Corporation	2019	2
+4	K212212	Multitom Rax with True2scale Body Scan Option	Siemens Medical Solutions	2022	—
+5	K221281	Multitom Rax	Siemens Medical Solutions	2022	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2014	1	0
2015	1	0
2019	2	0
2021	1	0
2022	2	0

FIG. 1 — Lineage of K052500, 2005–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

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What was it cleared against? (1)

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	Applicant	Decided	Recalls
*	K050925	Digital Radiography System Radspeed Safire Summary page 3 …is total patient population. As mentioned at "Intended Use" in this clearance letter, the intended use of DAR-8000f is the same as that of predicate device of DAR-7000(K050925). Consequently, the indications for use of DAR-8000f are also the same as that of DAR-7000, and there are no additional indic…	Shimadzu Corp.	2005	—

Also cleared against K050925: 2 other devices →

What descends from it? (8)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K131075	X-Ray TV System Sonial Vision G4	Shimadzu Corp.	2014	6
K072006	DAR-9400F	Shimadzu Corp.	2007	0

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jan 12, 2018	Class II	Z-2060-2018	Software design	When selecting serial radiography with a pulse rate of 7.5fps (including selecting a preset or changing the pulse rate using a temporary edit function) it was observed the indicated "irradiation time" on the X-ray Generator Console, as…
Apr 3, 2014	Class II	Z-1569-2014	Software design	Shimadzu Corporation is recalling the Shimadzu Digital X-Ray System because they have received a report of a lost image under certain circumstances.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no recall.
Of its descendants, K131075 (Shimadzu Corp., 2014) has gone furthest, with 6 descendants of its own.
2 other devices also cite its predicate K050925.

How does its category compare?

All IZI devices

IZI System, X-Ray, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IZI

2in 2025

2007high 7 (2007) · low 0 (2015)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IZI

81in 2023

2007high 111 (2014) · low 28 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IZI

1in 2021

2007high 52 (2008) · low 0 (2022)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IZI

2,171in 2025

2007high 2,171 (2025) · low 14 (2020)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 for the radiography in the hospital with X-ray devices.

This device is operated and used by the physicians and X-ray technologist.

The object of this device is total patient population.

Indications for use as stated in the FDA 510(k) statement.

https://510kreport.com/device/K052500 · printed Nov 6, 2026

Cite this page

510(k) Report. “K052500: DAR-8000F.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K052500

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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