510(k) · Cleared

Cleared

Newtom Vgi and Newtom 5G

K130442510(k) TraditionalCleared Jul 3, 2013132-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

Qr S.R.L. · OAS X-Ray, Tomography, Computed, Dental

Cleared on Jul 3, 2013 after a 132-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.

Decided: Jul 3, 2013
Review: 132 days
Class: Class II
Product code: OAS
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK130442 Newtom Vgi and Newtom 5GQr S.R.L. · 2013
Descendant · cites it directly · 0 of its ownK151612 NewTom VGi evoQr S.R.L. · 2016

Most influential descendants

Showing 1 of 1 · See all

K151612NewTom VGi evoQr S.R.L. · 2016 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K130442	Newtom Vgi and Newtom 5G	Qr S.R.L.	2013	—
+1	K151612	NewTom VGi evo	Qr S.R.L.	2016	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2016	1	0

FIG. 1 — Lineage of K130442, 2013–2016Source: 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 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’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K151612	NewTom VGi evo	Qr S.R.L.	2016	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?

Of its descendants, K151612 (Qr S.R.L., 2016) has gone furthest, with 0 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. 2013, 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?

NewTom VGi is a cone beam computed tomography x-ray imaging system that acquires a 360 degree rotational sequences of the head including the ENT, dento-maxillofacial complex, temporo-mandibular-joint (TMJ), other areas of human skull and neck with sections of upper cervical spine 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…

Read the full statement (221 words)

NewTom 5G is a cone beam computed tomography x-ray imaging system that acquires a 360 degree rotational sequences of the head including the ENT, dento-maxillofacial complex, temporo-mandibular-joint (TMVJ), other areas of human skull and neck with sections of upper cervical spine 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 is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.

NewTom 5G is especially designed for:

- dento-maxillo-facial complex imaging;

- teeth, mandible and jaw imaging for implant planning;

- temporal-mandibular joint (TMJ) imaging;

- ear, nose and throat (ENT) analysis;

- sections of upper cervical-spine imaging;

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

https://510kreport.com/device/K130442 · printed Nov 6, 2026

Cite this page

510(k) Report. “K130442: Newtom Vgi and Newtom 5G.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130442

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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