510(k) · Cleared
ClearedNewtom 3G QR-DVT 9000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Aperio Services, LLC · OAS X-Ray, Tomography, Computed, Dental
Cleared on May 14, 2004 as substantially equivalent to K003787 (Aperio Services, LLC, 2001) after a 14-day review. Its family tree reaches back 1 generation to 2001. 3 later devices descend from it.
- Decided
- May 14, 2004
- Review
- 14 days
- Class
- Class II
- Product code
- OAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K003787 (2001). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK003787 Newtom QR-DVT 9000Aperio Services, LLC · 2001
- This deviceK041137 Newtom 3G QR-DVT 9000Aperio Services, LLC · 2004
- Descendant · cites it directly · 2 of its ownK072357 Newtom VG Computed Tomography X-Ray SystemAfp Imaging Corp. · 2007
- Descendant · 2 generations on · 0 of its ownK133797 Qmaster-H/RevoTelesystems Co., Ltd. · 2014
- Descendant · 2 generations on · 0 of its ownK110260 Newtom 5G / Newtom 5G Version FPQr S.R.L. · 2011
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K003787 | Newtom QR-DVT 9000 | Aperio Services, LLC | 2001 | — |
| 0 (this device) | K041137 | Newtom 3G QR-DVT 9000 | Aperio Services, LLC | 2004 | — |
| +1 | K072357 | Newtom VG Computed Tomography X-Ray System | Afp Imaging Corp. | 2007 | — |
| +2 | K133797 | Qmaster-H/Revo | Telesystems Co., Ltd. | 2014 | — |
| +2 | K110260 | Newtom 5G / Newtom 5G Version FP | Qr S.R.L. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K003787 | Newtom QR-DVT 9000Summary page 1…n Name: Computed Tomography X-ray System Predicate Device Information: The predicate device is the NewTom model QR-DVT 9000 Computed Tomography X-ray System, [510(k) # K003787] this predicate device has been has been classified as Class 11, 90 JAA/ 9OMUH. The NewTom 3G model QR-DVT 9000 is substantially… | 2001 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K072357 | Newtom VG Computed Tomography X-Ray System | 2007 | 2 |
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?
How does its category compare?
All OAS devicesOAS X-Ray, Tomography, Computed, Dental: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · OAS
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OAS
144in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OAS
3in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OAS
1in 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 QR-DVT 9000 Computed Tomography X-ray System is a dedicated X-Ray imaging device that acquires a 360-degree rotational X-Ray sequence for use in diagnostic support in odontoiatric radiology (with a particular reference to patient evaluation and the monitoring of implantations) and in the field of maxillofacial surgery. This is the same intended use as previously cleared for the NewTom QR-DVT 9000 Computed Tomography X-ray System, [510 (k) #K003787].
The NewTom QR-DVT 9000 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K041137 · printed Nov 6, 2026
Cite this page
510(k) Report. “K041137: Newtom 3G QR-DVT 9000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041137
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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