510(k) · Cleared
Clearedrainbow MCT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dentium Co., Ltd (Ict Branch) · OAS X-Ray, Tomography, Computed, Dental
Cleared on Apr 16, 2021 as substantially equivalent to K181432 (Durr Dental SE, 2018) after a 437-day review. Its family tree reaches back 9 generations to 1997.
- Decided
- Apr 16, 2021
- Review
- 437 days
- Class
- Class II
- Product code
- OAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K973642 (1997). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 9 generations backK973642 Orthopantomograph OP100 and Orthoceph OC100Instrumentarium Imaging, Inc. · 1997
- 5 generations between
- 3 generations backK122606 PHT-6500; PHT-60CFO; Pax-I3DMtechgroup · 2012
- 2 generations backK152106 Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D SmartVATECH Co., Ltd. · 2015
- 1 generation backK181432 ProVectra 3D Prime with VistaSoftDurr Dental SE · 2018
- This deviceK200270 rainbow MCTDentium Co., Ltd (Ict Branch) · 2021
Show all 9 generations
- Root · 9 generations backK973642 Orthopantomograph OP100 and Orthoceph OC100Instrumentarium Imaging, Inc. · 1997
- 8 generations backK063773 Volumetric TomographyInstrumentarium Dental, Inc. · 2007
- 7 generations backK082350 PAX-500VATECH Co., Ltd. · 2008
- 6 generations backK090171 Computed Tomography X-Ray System, Pax-REVE3DE-Woo Technology · 2009
- 5 generations backK102259 Dental Computed Tomography X-Ray SystemVATECH Co., Ltd. · 2011
- 4 generations backK121412 Pax-FLEX3D, PHT-7000VATECH Co., Ltd. · 2012
- 3 generations backK122606 PHT-6500; PHT-60CFO; Pax-I3DMtechgroup · 2012
- 2 generations backK152106 Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D SmartVATECH Co., Ltd. · 2015
- 1 generation backK181432 ProVectra 3D Prime with VistaSoftDurr Dental SE · 2018
- This deviceK200270 rainbow MCTDentium Co., Ltd (Ict Branch) · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K973642 | Orthopantomograph OP100 and Orthoceph OC100 | Instrumentarium Imaging, Inc. | 1997 | — |
| −8 | K063773 | Volumetric Tomography | Instrumentarium Dental, Inc. | 2007 | — |
| −7 | K082350 | PAX-500 | VATECH Co., Ltd. | 2008 | — |
| −6 | K090171 | Computed Tomography X-Ray System, Pax-REVE3D | E-Woo Technology | 2009 | — |
| −5 | K102259 | Dental Computed Tomography X-Ray System | VATECH Co., Ltd. | 2011 | — |
| −4 | K121412 | Pax-FLEX3D, PHT-7000 | VATECH Co., Ltd. | 2012 | — |
| −3 | K122606 | PHT-6500; PHT-60CFO; Pax-I3D | Mtechgroup | 2012 | — |
| −2 | K152106 | Dental Computed Tomography X-ray System, PHT-30LFO, PaX-i3D Smart | VATECH Co., Ltd. | 2015 | — |
| −1 | K181432 | ProVectra 3D Prime with VistaSoft | Durr Dental SE | 2018 | — |
| 0 (this device) | K200270 | rainbow MCT | Dentium Co., Ltd (Ict Branch) | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 |
|---|---|---|---|
| * | K181432 | ProVectra 3D Prime with VistaSoftSummary page 4…750 Device Class II 4. Predicate Device: Legally Marketed Predicate Device Information: 510(k) Number: K181432 Trade /Proprietary Name: ProVecta 3D Prime with VistaSoft Device: X-Ray, T… | 2018 |
| † | K102196 | Computed Tomography X-Ray System | 2011 |
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 24 years and passes through 7 companies; a new generation was cleared every 1.8 years on median.
- None of the 10 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. 2021, 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?
rainbow MCT is a computed tomography x-ray system intended to produce 3D and panoramic diagnostic images of the maxillofacial areas for treatment planning for adult and pediatric patients. The device is operated and used by physicians, dentists, and x-ray technicians.
Rainbow 3D Image Viewer software features functions for acquiring, saving, searching, displaying, diagnosing and sending digital X-ray image data in dental practices and clinics.
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/K200270 · printed Nov 4, 2026
Cite this page
510(k) Report. “K200270: rainbow MCT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K200270
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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