510(k) · Cleared

Cleared

Finecube Dental CT

K063622510(k) TraditionalCleared Feb 8, 200765-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

The Yoshida Dental Mfg. Co., Ltd. · OAS X-Ray, Tomography, Computed, Dental

Cleared on Feb 8, 2007 as substantially equivalent to K051980 (Imaging Sciences Intl., Inc., 2005) and 1 other predicate after a 65-day review. Its family tree reaches back 3 generations to 1997. 11 later devices descend from it.

Decided: Feb 8, 2007
Review: 65 days
Class: Class II
Product code: OAS
Recalls: None
Predicates: 2

Its longest line of descent runs back 3 generations to K973598 (1997). 6 ancestors in all, the oldest K945375 (1995). 11 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 3 generations backK973598 Siremobil CO2Siemens Medical Solutions USA, Inc. · 1997 · Recalled
2 generations backK030450 3D Accu-I-Tomo Xyz Slice View TomographJ. Morita USA, Inc. · 2003
1 generation backK051980 DVT ScannerImaging Sciences Intl., Inc. · 2005 · Recalled
This deviceK063622 Finecube Dental CTThe Yoshida Dental Mfg. Co., Ltd. · 2007
Descendant · cites it directly · 6 of its ownK122199 PREXION3D EclipseThe Yoshida Dental Mfg. Co., Ltd. · 2013
Descendant · 2 generations on · 2 of its ownK161881 PreXion3D ExcelsiorPrexion Corporation · 2016
Descendant · 2 generations on · 2 of its ownK152489 ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-RayPanoramic Corp. · 2016
Descendant · cites it directly · 2 of its ownK072574 Alphard Cone Beam CT, Model X178Takara Belmont Corp. · 2007
Descendant · 3 generations on · 1 of its ownK210820 EAGLE EDGE AXR90 and AXR120Alliage S/A Industrias Medico Odontológica · 2021

Showing 5 of 11 descendants. See all descendants

Descendants cleared per year

2007high 2 (2013) · low 0 (2008)2026

Most influential descendants

Showing 5 of 11 · See all

K122199PREXION3D EclipseThe Yoshida Dental Mfg. Co., Ltd. · 2013 · cites it directly6descendants
K161881PreXion3D ExcelsiorPrexion Corporation · 2016 · 2 generations on2descendants
K152489ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-RayPanoramic Corp. · 2016 · 2 generations on2descendants
K072574Alphard Cone Beam CT, Model X178Takara Belmont Corp. · 2007 · cites it directly2descendants
K210820EAGLE EDGE AXR90 and AXR120Alliage S/A Industrias Medico Odontológica · 2021 · 3 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K973598	Siremobil CO2	Siemens Medical Solutions USA, Inc.	1997	1
−2	K030450	3D Accu-I-Tomo Xyz Slice View Tomograph	J. Morita USA, Inc.	2003	—
−1	K051980	DVT Scanner	Imaging Sciences Intl., Inc.	2005	3
0 (this device)	K063622	Finecube Dental CT	The Yoshida Dental Mfg. Co., Ltd.	2007	—
+1	K122199	PREXION3D Eclipse	The Yoshida Dental Mfg. Co., Ltd.	2013	—
+2	K161881	PreXion3D Excelsior	Prexion Corporation	2016	—
+2	K152489	ENCOMPASS Eagle 3D CBCT/Panoramic/Cephalometric Dental X-Ray	Panoramic Corp.	2016	—
+1	K072574	Alphard Cone Beam CT, Model X178	Takara Belmont Corp.	2007	—
+3	K210820	EAGLE EDGE AXR90 and AXR120	Alliage S/A Industrias Medico Odontológica	2021	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0
2000	1	0
2001	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2011	1	0
2012	1	0
2013	2	0
2016	2	0
2018	2	0
2021	1	0
2023	1	0

FIG. 1 — Lineage of K063622, 1997–2023Source: 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 OAS? 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 OAS device

#1 K213226 RCT700score 18.0 · 13 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
*	K051980	DVT Scanner Summary page 1 …ed Tomography X-Ray System Product Code 90 JAK Common/Usual Name: Dental CT 2. Equivalent legally marketed device: Imaging Sciences International Inc. DVT SCANNER K051980; J. Morita Manufacturing. Corporation. 3D Accu-1-torno XYZ Slice View Tomograph K030450 3. Indications for Use (intended use)…	Imaging Sciences Intl., Inc.	2005	3
*	K030450	3D Accu-I-Tomo Xyz Slice View Tomograph Summary page 1 …nt legally marketed device: Imaging Sciences International Inc. DVT SCANNER K051980; J. Morita Manufacturing. Corporation. 3D Accu-1-torno XYZ Slice View Tomograph K030450 3. Indications for Use (intended use) FineCube is an x-ray device (cone beam computed tomography) that acquires a single 360…	J. Morita USA, Inc.	2003	—

What descends from it? (11)

See all 11

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

Number	Device	Applicant	Decided	Descendants
K122199	PREXION3D Eclipse	The Yoshida Dental Mfg. Co., Ltd.	2013	6
K072574	Alphard Cone Beam CT, Model X178	Takara Belmont Corp.	2007	2
K120948	Prexion 3D	The Yoshida Dental Mfg. Co., Ltd.	2012	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?

The line of descent spans 10 years and passes through 4 companies; a new generation was cleared every 2.3 years on median.
3 of the 6 ancestors have a recall of any class.
Of its descendants, K122199 (The Yoshida Dental Mfg. Co., Ltd., 2013) has gone furthest, with 6 descendants of its own.

How does its category compare?

All OAS devices

OAS X-Ray, Tomography, Computed, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · OAS

9in 2025

2007high 12 (2016) · low 1 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OAS

144in 2025

2007high 209 (2017) · low 55 (2019)2026

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

Recalls per year · OAS

3in 2025

2007high 3 (2025) · low 0 (2007)2026

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

Adverse event reports per year · OAS

1in 2025

2007high 2 (2024) · low 0 (2007)2025

MAUDE reports naming product code OAS, 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	2	—	0	0
2008	2	—	0	1
2009	2	—	0	0
2010	1	—	0	0
2011	6	168	0	0
2012	7	110	0	0
2013	10	155	0	0
2014	5	170	0	0
2015	5	164	1	0
2016	12	154	0	0
2017	4	209	0	0
2018	11	57	0	0
2019	7	55	0	1
2020	9	113	0	0
2021	11	92	0	0
2022	6	105	0	1
2023	12	77	0	1
2024	4	129	0	2
2025	9	144	3	1
2026	9	77	0	—

What is it indicated for?

FineCube is an x-ray device (cone beam computed tomography) that acquires a single 360 degree rotational sequence of the head and neck areas, including the ENT and dentomaxillofacial area for use in diagnostic support. 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/K063622 · printed Nov 5, 2026

Cite this page

510(k) Report. “K063622: Finecube Dental CT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K063622

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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