510(k) · Cleared

Cleared

NewTom VGi evo

K151612510(k) TraditionalCleared Mar 31, 2016290-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 Mar 31, 2016 as substantially equivalent to K130442 (Qr S.R.L., 2013) after a 290-day review. Its family tree reaches back 1 generation to 2013.

Decided: Mar 31, 2016
Review: 290 days
Class: Class II
Product code: OAS
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K130442 (2013). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK130442 Newtom Vgi and Newtom 5GQr S.R.L. · 2013
This deviceK151612 NewTom VGi evoQr S.R.L. · 2016

View FIG. 1 as a table

Line of descent and top descendants

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

FIG. 1 — Lineage of K151612, 2013–2016Source: 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? (1)

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
*	K130442	Newtom Vgi and Newtom 5G Summary page 6 …No : 21CFR 892.1750, Class II Product Code: OAS 510(k) Number: K130442 IV. DEVICE DESCRIPTION The medical electrical equipment NewTom VGi evo is an X-ray imaging device comprising an X-ray acqu…	Qr S.R.L.	2013	—

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?

Its one ancestor has no recall.

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. 2016, 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?

The NewTom VGi evo is a cone beam computed tomographic x-ray imaging system that acquires 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 (tomographic sections, pan and ceph projections) displaying both two and three dimensional images. The device is operated and used by physicians, dentists, x-ray technologists and other legally qualified professionals.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K151612 · printed Nov 6, 2026

Cite this page

510(k) Report. “K151612: NewTom VGi evo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151612

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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