510(k) · Cleared

Cleared

3D Accu-I-Tomo Xyz Slice View Tomograph

K030450510(k) TraditionalCleared May 6, 200384-day reviewClass II21 CFR 892.1750

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. · JAK System, X-Ray, Tomography, Computed

Cleared on May 6, 2003 as substantially equivalent to K973598 (Siemens Medical Solutions USA, Inc., 1997) and 2 other predicates after an 84-day review. Its family tree reaches back 1 generation to 1997. 88 later devices descend from it.

Decided: May 6, 2003
Review: 84 days
Class: Class II
Product code: JAK
Recalls: None
Predicates: 3

Its longest line of descent runs back 1 generation to K973598 (1997). 3 ancestors in all. 88 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 1 generation backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
This deviceK030450 3D Accu-I-Tomo Xyz Slice View TomographJ. Morita USA, Inc. · 2003
Descendant · cites it directly · 66 of its ownK052587 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 ExfJ. Morita USA, Inc. · 2005
Descendant · 2 generations on · 61 of its ownK060328 Planmeca Promax 3DPlanmeca Oy · 2006
Descendant · cites it directly · 31 of its ownK061284 I-Cat ScannerImaging Sciences Intl., Inc. · 2006 · Recalled
Descendant · 3 generations on · 27 of its ownK111152 Rotograph Evo 3DVilla Sistemi Medicali S.P.A. · 2011 · Recalled
Descendant · 4 generations on · 24 of its ownK122981 Rayscan a-Expert 3DRay Co., Ltd. · 2013

Showing 5 of 88 descendants. See all descendants

Descendants cleared per year

2003high 11 (2018) · low 0 (2004)2026

Most influential descendants

Showing 5 of 88 · See all

K0525873D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 ExfJ. Morita USA, Inc. · 2005 · cites it directly66descendants
K060328Planmeca Promax 3DPlanmeca Oy · 2006 · 2 generations on61descendants
K061284I-Cat ScannerImaging Sciences Intl., Inc. · 2006 · cites it directly31descendants
K111152Rotograph Evo 3DVilla Sistemi Medicali S.P.A. · 2011 · 3 generations on27descendants
K122981Rayscan a-Expert 3DRay Co., Ltd. · 2013 · 4 generations on24descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K973598	Siremobil CO2	Siemens Medical Solutions USA, Inc.	1997	1
0 (this device)	K030450	3D Accu-I-Tomo Xyz Slice View Tomograph	J. Morita USA, Inc.	2003	—
+1	K052587	3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 Exf	J. Morita USA, Inc.	2005	—
+2	K060328	Planmeca Promax 3D	Planmeca Oy	2006	—
+1	K061284	I-Cat Scanner	Imaging Sciences Intl., Inc.	2006	2
+3	K111152	Rotograph Evo 3D	Villa Sistemi Medicali S.P.A.	2011	1
+4	K122981	Rayscan a-Expert 3D	Ray Co., Ltd.	2013	—

Other ancestors by year cleared

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2005	2	0
2006	3	0
2007	3	0
2008	5	0
2010	2	0
2011	5	0
2012	3	0
2013	9	0
2014	2	0
2015	2	0
2016	8	0
2017	3	0
2018	11	0
2019	2	0
2020	2	0
2021	6	0
2022	2	0
2023	5	0
2024	1	0
2025	5	0
2026	6	0

FIG. 1 — Lineage of K030450, 1997–2026Source: 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 JAK? 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 JAK device

#1 K230223 iCAC Devicescore 23.5 · 12 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? (3)

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
*	K973598	Siremobil CO2 Summary page 2 …n the testing mode, it can take but not save a moving image. The 3D Accu-I-tom0 is substantially equivalent to the (i) Siemens Medical Systems’ Siremobil C02 (K#973598), (ii), Siemens Siremobil Iso-C 3D Imaging Option (K#003266), and (iii) NIM s.r.l.’s NewTom Model QR-DVT 9000 (K#003787). The 3D…	Siemens Medical Solutions USA, Inc.	1997	1
*	K003266	Siremobil Iso-C 3D Summary page 2 …The 3D Accu-I-tom0 is substantially equivalent to the (i) Siemens Medical Systems’ Siremobil C02 (K#973598), (ii), Siemens Siremobil Iso-C 3D Imaging Option (K#003266), and (iii) NIM s.r.l.’s NewTom Model QR-DVT 9000 (K#003787). The 3D Accu-I-tom0 has similar general intended uses, principles of…	Siemens Medical Solutions USA, Inc.	2000	—
*	K003787	Newtom QR-DVT 9000 Summary page 2 …the (i) Siemens Medical Systems’ Siremobil C02 (K#973598), (ii), Siemens Siremobil Iso-C 3D Imaging Option (K#003266), and (iii) NIM s.r.l.’s NewTom Model QR-DVT 9000 (K#003787). The 3D Accu-I-tom0 has similar general intended uses, principles of operation, and technological characteristics as the previou…	Aperio Services, LLC	2001	—

Also cleared against K973598: 6 other devices →

What descends from it? (88)

See all 88

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

Number	Device	Applicant	Decided	Descendants
K052587	3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 Exf	J. Morita USA, Inc.	2005	66
K061284	I-Cat Scanner	Imaging Sciences Intl., Inc.	2006	31
K051980	DVT Scanner	Imaging Sciences Intl., Inc.	2005	12
K063622	Finecube Dental CT	The Yoshida Dental Mfg. Co., Ltd.	2007	11
K032243	Minicat Dentocat	Xoran Technologies, Inc.	2003	9
K073704	I-Dixel	J. Morita USA, Inc.	2008	0

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?

1 of the 3 ancestors has a recall of any class.
Of its descendants, K052587 (J. Morita USA, Inc., 2005) has gone furthest, with 66 descendants of its own.
6 other devices also cite its predicate K973598.

How does its category compare?

All JAK devices

JAK System, X-Ray, Tomography, Computed: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · JAK

27in 2025

2007high 30 (2014) · low 7 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · JAK

141in 2025

2007high 200 (2014) · low 27 (2007)2026

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

Recalls per year · JAK

17in 2025

2007high 51 (2010) · low 5 (2019)2026

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

Adverse event reports per year · JAK

219in 2025

2007high 543 (2018) · low 76 (2007)2025

MAUDE reports naming product code JAK, 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	14	27	11	76
2008	26	42	16	120
2009	15	31	29	105
2010	7	92	51	119
2011	16	155	34	205
2012	28	121	23	192
2013	17	132	11	414
2014	30	200	10	308
2015	30	140	28	454
2016	25	129	44	365
2017	29	96	33	338
2018	24	114	10	543
2019	28	94	5	233
2020	30	112	8	177
2021	20	145	15	261
2022	30	131	9	199
2023	27	139	9	310
2024	26	141	20	212
2025	27	141	17	219
2026	21	167	23	—

What is it indicated for?

The 3D Accu-I-tom0 is an x-ray imaging device that acquires a 360 degree rotational sequence of the head and neck areas, including the ENT and dento-maxillofacial areas, for use in diagnostic support. The device accomplishes this task by reconstructing a three-dimensional matrix of the examined volume and producing two-dimensional views of this volume, displaying both two- and three-dimensional images. The device can also be used for fluoroscopy during surgery, mostly for ENT and TMJ applications and mostly with a contrast medium. The device is operated and used by physicians, dentists, and x-ray technologists.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030450 · printed Nov 6, 2026

Cite this page

510(k) Report. “K030450: 3D Accu-I-Tomo Xyz Slice View Tomograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K030450

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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