# K200271: rainbow CT

- Pathway: 510(k) (Traditional)
- Applicant: Dentium Co., Ltd (Ict Branch)
- Decided: Apr 16, 2021 after 437 days
- Product code: OAS (X-Ray, Tomography, Computed, Dental)
- Device class: 2
- Regulation: 21 CFR 892.1750
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K193139 (2020). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K193139: ProVecta 3D Prime Ceph, Durr Dental SE (2020). Cleared while this submission was under review Summary page 4.

## Most influential descendants
- K231181: bright CT (2023), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K200271
Methodology: https://510kreport.com/methodology