510(k) · Cleared

Cleared

I-Dixel

K073704510(k) TraditionalCleared Feb 21, 200852-day reviewClass II21 CFR 892.2050

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

J. Morita USA, Inc. · LLZ System, Image Processing, Radiological

Cleared on Feb 21, 2008 as substantially equivalent to K030450 (J. Morita USA, Inc., 2003) after a 52-day review. Its family tree reaches back 2 generations to 1997.

Decided: Feb 21, 2008
Review: 52 days
Class: Class II
Product code: LLZ
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K973598 (1997). 4 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
1 generation backK030450 3D Accu-I-Tomo Xyz Slice View TomographJ. Morita USA, Inc. · 2003
This deviceK073704 I-DixelJ. Morita USA, Inc. · 2008

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K973598	Siremobil CO2	Siemens Medical Solutions USA, Inc.	1997	1
−1	K030450	3D Accu-I-Tomo Xyz Slice View Tomograph	J. Morita USA, Inc.	2003	—
0 (this device)	K073704	I-Dixel	J. Morita USA, Inc.	2008	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2001	1	0

FIG. 1 — Lineage of K073704, 1997–2008Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 LLZ? 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 LLZ device

#1 K230955 syngo Application Softwarescore 21.5 · 11 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? (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	Applicant	Decided	Recalls
*	K030450	3D Accu-I-Tomo Xyz Slice View Tomograph Summary page 2 …=== i-Dixel is practically the same as 3DX Integrated Information System, which is incorporated in our legally marketed device, 3D Accu-I-tomo XYZ Slice View Tomograph (K030450). i-Dixel is also presumably the same as N-Liten which is incorporated to ProMax 3D (Planmeca Oy, Finland). 6. Description of t…	J. Morita USA, Inc.	2003	—
*	—	N-Liten (incorporated into ProMax 3D) Named without a submission number			—

Also cleared against K030450: 5 other devices →

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 11 years and passes through 2 companies; a new generation was cleared every 5.5 years on median.
1 of the 4 ancestors has a recall of any class.
5 other devices also cite its predicate K030450.

How does its category compare?

All LLZ devices

LLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.

FDA decisions per year · LLZ

58in 2025

2007high 106 (2011) · low 51 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · LLZ

173in 2025

2007high 173 (2025) · low 36 (2007)2026

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

Recalls per year · LLZ

11in 2025

2007high 64 (2013) · low 2 (2019)2026

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

Adverse event reports per year · LLZ

116in 2025

2007high 15,631 (2014) · low 26 (2023)2025

MAUDE reports naming product code LLZ, 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	76	36	20	152
2008	94	52	32	154
2009	70	62	21	145
2010	51	98	17	145
2011	106	79	30	454
2012	82	87	12	266
2013	95	84	64	1,130
2014	78	89	6	15,631
2015	64	90	16	211
2016	82	90	12	290
2017	78	107	5	104
2018	104	105	7	72
2019	74	107	2	88
2020	81	115	6	82
2021	83	116	3	70
2022	65	137	4	28
2023	87	157	8	26
2024	62	131	6	42
2025	58	173	11	116
2026	45	110	14	—

What is it indicated for?

i-Dixel is a software for management of images obtained from x-ray imaging equipment and other imaging modalities. i-Dixel is used for medical and dental image examination and diagnosis.

The software is to be operated and used by doctor, dentists and other legally qualified professionals.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K073704 · printed Nov 4, 2026

Cite this page

510(k) Report. “K073704: I-Dixel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K073704

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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