510(k) · Cleared
Clearedrainbow CT
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 K193139 (Durr Dental SE, 2020) after a 437-day review. Its family tree reaches back 1 generation to 2020. 1 later device descends from it.
- Decided
- Apr 16, 2021
- Review
- 437 days
- Class
- Class II
- Product code
- OAS
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K193139 (2020). 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K231181bright CTDentium Co., Ltd (Ict Branch) · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K193139 | ProVecta 3D Prime Ceph | Durr Dental SE | 2020 | — |
| 0 (this device) | K200271 | rainbow CT | Dentium Co., Ltd (Ict Branch) | 2021 | — |
| +1 | K231181 | bright CT | Dentium Co., Ltd (Ict Branch) | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 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 |
|---|---|---|---|
| * | K193139 | ProVecta 3D Prime Ceph Cleared while this submission was under review Summary page 4…1750 Device Class 2 4. Predicate Device: Legally Marketed Predicate Device Information: 510(k) Number: K193139 Trade /Proprietary Name: ProVecta 3D Prime Ceph Device: X-Ray, Tomography,… | 2020 |
| † | K172614 | Caldera Medical Transobturator Helical Introducer, Left; Caldera Medical Transobturator… | 2018 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231181 | bright CT | 2023 | 0 |
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. 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 CT is a computed tomography x-ray system intended to produce 3D, panoramic, and cephalometric 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/K200271 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200271: rainbow CT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200271
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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