510(k) · Cleared
ClearedNewtom VG Computed Tomography X-Ray System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Afp Imaging Corp. · MUH System, X-Ray, Extraoral Source, Digital
Cleared on Sep 18, 2007 as substantially equivalent to K041137 (Aperio Services, LLC, 2004) after a 27-day review. Its family tree reaches back 2 generations to 2001. 2 later devices descend from it.
- Decided
- Sep 18, 2007
- Review
- 27 days
- Class
- Class II
- Product code
- MUH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K003787 (2001). 2 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK003787 Newtom QR-DVT 9000Aperio Services, LLC · 2001
- 1 generation backK041137 Newtom 3G QR-DVT 9000Aperio Services, LLC · 2004
- This deviceK072357 Newtom VG Computed Tomography X-Ray SystemAfp Imaging Corp. · 2007
- Descendant · cites it directly · 0 of its ownK133797 Qmaster-H/RevoTelesystems Co., Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK110260 Newtom 5G / Newtom 5G Version FPQr S.R.L. · 2011
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K003787 | Newtom QR-DVT 9000 | Aperio Services, LLC | 2001 | — |
| −1 | K041137 | Newtom 3G QR-DVT 9000 | Aperio Services, LLC | 2004 | — |
| 0 (this device) | K072357 | Newtom VG Computed Tomography X-Ray System | Afp Imaging Corp. | 2007 | — |
| +1 | K133797 | Qmaster-H/Revo | Telesystems Co., Ltd. | 2014 | — |
| +1 | K110260 | Newtom 5G / Newtom 5G Version FP | Qr S.R.L. | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 MUH? 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 MUH device
- #1 K242778 X Sensor (Model: IOS-A15IF, HDI-15DGF)score 16.0 · 7 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 |
|---|---|---|---|
| * | K041137 | Newtom 3G QR-DVT 9000Summary page 1…ame: X-Ray System Classification Name: Computed Tomography X-Ray System 3. PREDICATE DEVICES NewTorn 3G Computed Tomography X-Ray System K041 137 4. DEVICE DESCRIPTION The NewTom VG Computed Tomography X-Ray System (NewTom VG) is a dedicated X-ray imaging d… | 2004 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 6 years and passes through 2 companies; a new generation was cleared every 3.3 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K133797 (Telesystems Co., Ltd., 2014) has gone furthest, with 0 descendants of its own.
How does its category compare?
All MUH devicesMUH System, X-Ray, Extraoral Source, Digital: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · MUH
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUH
159in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUH
1in 2015
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUH
1in 2025
MAUDE reports naming product code MUH, 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 | 11 | 48 | 0 | 0 |
| 2008 | 8 | 64 | 1 | 0 |
| 2009 | 9 | 88 | 2 | 12 |
| 2010 | 9 | 174 | 0 | 9 |
| 2011 | 10 | 89 | 0 | 0 |
| 2012 | 9 | 81 | 0 | 5 |
| 2013 | 9 | 172 | 1 | 1 |
| 2014 | 8 | 168 | 1 | 5 |
| 2015 | 12 | 111 | 1 | 3 |
| 2016 | 6 | 47 | 0 | 1 |
| 2017 | 9 | 84 | 0 | 4 |
| 2018 | 3 | 29 | 0 | 10 |
| 2019 | 5 | 64 | 0 | 6 |
| 2020 | 5 | 36 | 0 | 0 |
| 2021 | 10 | 80 | 0 | 1 |
| 2022 | 7 | 57 | 0 | 0 |
| 2023 | 11 | 57 | 0 | 1 |
| 2024 | 4 | 144 | 0 | 0 |
| 2025 | 3 | 159 | 0 | 1 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
The NewTom VG Computed Tomography X-ray System is a dedicated X-ray imaging device that acquires a 360-degree rotational X-ray sequence of images for use as diagnostic support in radiology of the dento-maxillo-facial complex and in the field of maxillofacial surgery.
The NewTom VG accomplishes this task by reconstructing a three-dimensional matrix of the examined volume, producing two-dimensional views of this volume and displaying both two-dimensional images and three-dimensional renderings.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072357 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072357: Newtom VG Computed Tomography X-Ray System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072357
Report an extraction error
Are you the manufacturer?
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