510(k) · Cleared
ClearedQmaster-H/Revo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Telesystems Co., Ltd. · OAS X-Ray, Tomography, Computed, Dental
Cleared on Sep 4, 2014 as substantially equivalent to K113497 (Cefla S.C. Cefla Dental Group, 2012) and 2 other predicates after a 265-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Sep 4, 2014
- Review
- 265 days
- Class
- Class II
- Product code
- OAS
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K972312 (1997). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK972312 Siemens Orthophos DS/DS CephSiemens AG · 1997
- 3 generations backK013650 Orthophos DS/DC Ceph, Orthophos 5/Plus/CDSirona Dental Systems GmbH · 2001
- 2 generations backK033073 Orthophos XG DS/CephSirona Dental Systems GmbH · 2003
- 1 generation backK103711 Orthophos XG 3D / CephSirona Dental Systems GmbH · 2011
- This deviceK133797 Qmaster-H/RevoTelesystems Co., Ltd. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K972312 | Siemens Orthophos DS/DS Ceph | Siemens AG | 1997 | — |
| −3 | K013650 | Orthophos DS/DC Ceph, Orthophos 5/Plus/CD | Sirona Dental Systems GmbH | 2001 | — |
| −2 | K033073 | Orthophos XG DS/Ceph | Sirona Dental Systems GmbH | 2003 | — |
| −1 | K103711 | Orthophos XG 3D / Ceph | Sirona Dental Systems GmbH | 2011 | — |
| 0 (this device) | K133797 | Qmaster-H/Revo | Telesystems Co., Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2012 | 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? (3)
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 |
|---|---|---|---|
| * | K113497 | HyperionSummary page 5…CBCT) X-Ray System Classification Name: Dental Computed Tomography X-Ray System (21 CFR 892.1750, Product Code OAS) Predicate Devices: Hyperion (K113497); Cefla Dental/MyRay, Italy Orthophos XG (K103711); Sirona Dental, Germany NewTom VG… | 2012 |
| * | K103711 | Orthophos XG 3D / CephSummary page 5…System (21 CFR 892.1750, Product Code OAS) Predicate Devices: Hyperion (K113497); Cefla Dental/MyRay, Italy Orthophos XG (K103711); Sirona Dental, Germany NewTom VG (K072357); Cefla Dental/QR, Italy Device Description: QRmaster-H/Revo i… | 2011 |
| * | K072357 | Newtom VG Computed Tomography X-Ray SystemSummary page 5…Predicate Devices: Hyperion (K113497); Cefla Dental/MyRay, Italy Orthophos XG (K103711); Sirona Dental, Germany NewTom VG (K072357); Cefla Dental/QR, Italy Device Description: QRmaster-H/Revo is an extraoral 2D (panoramic) and 3D (CBCT) x-ray imaging s… | 2007 |
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?
- The line of descent spans 17 years and passes through 3 companies; a new generation was cleared every 4.2 years on median.
- None of the 11 ancestors has a recall.
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. 2014, this device’s year, is highlighted.
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?
QRmaster-H/Revo 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 device accomplishes this task by reconstructing a three-dimensional matrix of the examined volume, producing two-dimensional views of this volume, and displaying both 2D images and 3D renderings. This technique is known as cone beam computed tomography, or CBCT.
All devices are sold by or on the order of a physician. They are not for use by the general public or over-the-counter.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133797 · printed Nov 4, 2026
Cite this page
510(k) Report. “K133797: Qmaster-H/Revo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K133797
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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