510(k) · Cleared

Cleared

Newtom QR-DVT 9000

K003787510(k) TraditionalCleared Mar 8, 200190-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

Aperio Services, LLC · OAS X-Ray, Tomography, Computed, Dental

Cleared on Mar 8, 2001 after a 90-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 104 later devices descend from it.

Decided: Mar 8, 2001
Review: 90 days
Class: Class II
Product code: OAS
Recalls: None
Predicates: 0

104 later devices descend from it, 6 citing it directly.

This deviceK003787 Newtom QR-DVT 9000Aperio Services, LLC · 2001
Descendant · cites it directly · 88 of its ownK030450 3D Accu-I-Tomo Xyz Slice View TomographJ. Morita USA, Inc. · 2003
Descendant · 2 generations on · 66 of its ownK052587 3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 ExfJ. Morita USA, Inc. · 2005
Descendant · 3 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 · 4 generations on · 27 of its ownK111152 Rotograph Evo 3DVilla Sistemi Medicali S.P.A. · 2011 · Recalled

Showing 5 of 104 descendants. See all descendants

Descendants cleared per year

2003high 11 (2018) · low 0 (2009)2026

Most influential descendants

Showing 5 of 104 · See all

K0304503D Accu-I-Tomo Xyz Slice View TomographJ. Morita USA, Inc. · 2003 · cites it directly88descendants
K0525873D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 ExfJ. Morita USA, Inc. · 2005 · 2 generations on66descendants
K060328Planmeca Promax 3DPlanmeca Oy · 2006 · 3 generations on61descendants
K061284I-Cat ScannerImaging Sciences Intl., Inc. · 2006 · cites it directly31descendants
K111152Rotograph Evo 3DVilla Sistemi Medicali S.P.A. · 2011 · 4 generations on27descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K003787	Newtom QR-DVT 9000	Aperio Services, LLC	2001	—
+1	K030450	3D Accu-I-Tomo Xyz Slice View Tomograph	J. Morita USA, Inc.	2003	—
+2	K052587	3D Accu-I-Tomo Xyz Slice View Tomograph, Model MCT-1 Exf	J. Morita USA, Inc.	2005	—
+3	K060328	Planmeca Promax 3D	Planmeca Oy	2006	—
+1	K061284	I-Cat Scanner	Imaging Sciences Intl., Inc.	2006	2
+4	K111152	Rotograph Evo 3D	Villa Sistemi Medicali S.P.A.	2011	1

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	3	0
2004	1	0
2005	2	0
2006	4	0
2007	4	0
2008	5	0
2010	3	0
2011	7	0
2012	3	0
2013	10	0
2014	3	0
2015	3	0
2016	9	0
2017	3	0
2018	11	0
2019	3	0
2020	3	0
2021	6	0
2022	3	0
2023	5	0
2024	1	0
2025	5	0
2026	7	0

FIG. 1 — Lineage of K003787, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (104)

See all 104

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

Number	Device	Applicant	Decided	Descendants
K030450	3D Accu-I-Tomo Xyz Slice View Tomograph	J. Morita USA, Inc.	2003	88
K061284	I-Cat Scanner	Imaging Sciences Intl., Inc.	2006	31
K033248	Hitachi CB Mercuray Dental Cone-Beam X-Ray System	Hitachi Medical Systems America, Inc.	2003	18
K051980	DVT Scanner	Imaging Sciences Intl., Inc.	2005	12
K032243	Minicat Dentocat	Xoran Technologies, Inc.	2003	9
K041137	Newtom 3G QR-DVT 9000	Aperio Services, LLC	2004	3

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?

Of its descendants, K030450 (J. Morita USA, Inc., 2003) has gone furthest, with 88 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.

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	—

https://510kreport.com/device/K003787 · printed Nov 4, 2026

Cite this page

510(k) Report. “K003787: Newtom QR-DVT 9000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K003787

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026