510(k) · Cleared
ClearedR2 Studio Q/RCT820
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Megagen Implant Co., Ltd. · OAS X-Ray, Tomography, Computed, Dental
Cleared on Dec 6, 2022 as substantially equivalent to K192737 (Ray Co., Ltd., 2019) after a 134-day review. Its family tree reaches back 13 generations to 1997.
- Decided
- Dec 6, 2022
- Review
- 134 days
- Class
- Class II
- Product code
- OAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 13 generations to K973642 (1997). 34 ancestors in all, the oldest K961826 (1996). No later device cites it as a predicate yet.
- Root · 13 generations backK973642 Orthopantomograph OP100 and Orthoceph OC100Instrumentarium Imaging, Inc. · 1997
- 9 generations between
- 3 generations backK181452 RCT800Ray Co., Ltd. · 2018
- 2 generations backK182805 RCT800Ray Co., Ltd. · 2018
- 1 generation backK192737 RCT800Ray Co., Ltd. · 2019
- This deviceK222219 R2 Studio Q/RCT820Megagen Implant Co., Ltd. · 2022
Show all 13 generations
- Root · 13 generations backK973642 Orthopantomograph OP100 and Orthoceph OC100Instrumentarium Imaging, Inc. · 1997
- 12 generations backK063773 Volumetric TomographyInstrumentarium Dental, Inc. · 2007
- 11 generations backK082350 PAX-500VATECH Co., Ltd. · 2008
- 10 generations backK090171 Computed Tomography X-Ray System, Pax-REVE3DE-Woo Technology · 2009
- 9 generations backK102259 Dental Computed Tomography X-Ray SystemVATECH Co., Ltd. · 2011
- 8 generations backK121412 Pax-FLEX3D, PHT-7000VATECH Co., Ltd. · 2012
- 7 generations backK122606 PHT-6500; PHT-60CFO; Pax-I3DMtechgroup · 2012
- 6 generations backK152106 Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D SmartVATECH Co., Ltd. · 2015
- 5 generations backK162660 Green Smart (Model: PHT-35LHS)VATECH Co., Ltd. · 2016
- 4 generations backK170066 Green16/Green18 (Model: PHT-65LHS)VATECH Co., Ltd. · 2017
- 3 generations backK181452 RCT800Ray Co., Ltd. · 2018
- 2 generations backK182805 RCT800Ray Co., Ltd. · 2018
- 1 generation backK192737 RCT800Ray Co., Ltd. · 2019
- This deviceK222219 R2 Studio Q/RCT820Megagen Implant Co., Ltd. · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K973642 | Orthopantomograph OP100 and Orthoceph OC100 | Instrumentarium Imaging, Inc. | 1997 | — |
| −12 | K063773 | Volumetric Tomography | Instrumentarium Dental, Inc. | 2007 | — |
| −11 | K082350 | PAX-500 | VATECH Co., Ltd. | 2008 | — |
| −10 | K090171 | Computed Tomography X-Ray System, Pax-REVE3D | E-Woo Technology | 2009 | — |
| −9 | K102259 | Dental Computed Tomography X-Ray System | VATECH Co., Ltd. | 2011 | — |
| −8 | K121412 | Pax-FLEX3D, PHT-7000 | VATECH Co., Ltd. | 2012 | — |
| −7 | K122606 | PHT-6500; PHT-60CFO; Pax-I3D | Mtechgroup | 2012 | — |
| −6 | K152106 | Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart | VATECH Co., Ltd. | 2015 | — |
| −5 | K162660 | Green Smart (Model: PHT-35LHS) | VATECH Co., Ltd. | 2016 | — |
| −4 | K170066 | Green16/Green18 (Model: PHT-65LHS) | VATECH Co., Ltd. | 2017 | — |
| −3 | K181452 | RCT800 | Ray Co., Ltd. | 2018 | — |
| −2 | K182805 | RCT800 | Ray Co., Ltd. | 2018 | — |
| −1 | K192737 | RCT800 | Ray Co., Ltd. | 2019 | — |
| 0 (this device) | K222219 | R2 Studio Q/RCT820 | Megagen Implant Co., Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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.
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 25 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 34 ancestors have a recall of any class.
- 2 other devices also cite its predicate K192737.
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. 2022, 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?
R2 STUDIO Q/RCT820 is CBCT and panoramic x-ray imaging system with cephalometric. Which is intended to radiographic examination of the dento-maxillofacial, sinus, TMJ, Airway for diagnostic support for adult and pediatric patients. And a model scan is included as an option. Cephalometric image is also includes wrist to obtain carpus images for growth and maturity assessment for orthodontic treatment. The device is to be operated and used by dentists or…
Read the full statement (116 words)
R2 STUDIO Q/RCT820 is CBCT and panoramic x-ray imaging system with cephalometric.
Which is intended to radiographic examination of the dento-maxillofacial, sinus, TMJ, Airway for diagnostic support for adult and pediatric patients. And a model scan is included as an option.
Cephalometric image is also includes wrist to obtain carpus images for growth and maturity assessment for orthodontic treatment.
The device is to be operated and used by dentists or other legally qualified health care professionals.
This device is not intended for use on patients less than approximately 21 kg (46 lb) in weight and 113 cm (44.5 in) in height; these height and weight measurements approximately correspond to that of an average 5 year old.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222219 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222219: R2 Studio Q/RCT820.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222219
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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