Skip to content

rainbow CT

by Dentium Co., Ltd. (ICT Branch) South Korea EUDAMED510(k)GUDID

510(k) K200271Ref ICT-R01-L, ICT-R01, ICT-R01-OModel ICT- R01-O

Product code OASEMDN Z1103030102

Overview

The Rainbow CT is a Computed Tomography Device, Dental, designed for high-resolution imaging of dental and maxillofacial structures. It employs cone-beam computed tomography (CBCT) technology to generate detailed cross-sectional images, enabling precise assessment of teeth, bone, and surrounding anatomy for diagnostic and treatment planning purposes.

This system is intended for use in dental and radiology settings, supplied as a reusable medical device. It operates under FDA 510(k) clearance and MDD authorization, adhering to Class II regulatory classification. The device is non-sterile and requires proper calibration and maintenance in accordance with manufacturer guidelines to ensure accurate imaging performance.

Summary written by AI from registry data, 18 Sep 2026.Not verified

About this summary

This description and any FAQs on this page were generated automatically and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08809544906357 Basic UDI-DIDate17 Nov 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number08809544906357 UDI-DIDate22 Apr 2021ListedStatusIn distribution
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK200271 Date16 Apr 2021ClearedStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring (legacy directive)
  • Not covered
  • European Union CE/MDD Expiring (legacy directive)
  • United States FDA 510(k) Active

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · GUDID · synced 22 Oct 2026

Generic Name
Stationary panoramic/tomographic dental x-ray system, digital
Model / Reference
ICT-R01-L, ICT-R01, ICT- R01-O, ICT-R01-O
FDA applicant
Dentium Co., Ltd (Ict Branch)
Primary DI / UDI-DI
08809544906357, 08809544906340, 08809162708791
Basic UDI-DI
B-08809544906357, B-08809544906340, B-08809162708791
510(k) Number
FDA Product Code
OAS
EMDN Code
Z1103030102 Equipment for extraoral dental radiology, digital
GMDN Term
Stationary panoramic/tomographic dental x-ray system, digital
Device Class
Class IIb EUDAMED
Class II 510(k)GUDID
Regulation
21 CFR Part 892.1750
Market of Registration
Türkiye
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent
Commercial Distribution
In Commercial Distribution

Truth per registry

3 sources · 1 field differs

FieldEUDAMED510(k)GUDID
Device ClassEUDAMED
Class IIb
510(k)
Class II
GUDID
Class II

Other devices from Dentium Co., Ltd. (ICT Branch)

  • bright CT

    Class IIb

  • rainbow MCT

    Class II

  • Intraoral Sensor

    Class II

  • bright Alone

    Class IIa

  • iCTmotor

    Class IIa

  • bright CT

    Class IIb

See all devices from Dentium Co., Ltd. (ICT Branch) →

Questions

  • What types of clinical settings is the Rainbow CT designed for and what specific anatomical structures does it image?

    The Rainbow CT is specifically designed for dental and radiology settings, where it provides high-resolution imaging of dental and maxillofacial structures. It uses cone-beam computed tomography (CBCT) technology to generate detailed cross-sectional images of teeth, bone, and surrounding anatomy, aiding in diagnostic assessments and treatment planning.

  • Is the Rainbow CT a single-use or reusable device, and what maintenance is required to ensure accurate imaging?

    The Rainbow CT is a reusable medical device. To maintain accurate imaging performance, it requires proper calibration and regular maintenance as outlined by the manufacturer’s guidelines. This ensures consistent and reliable operation over time.

  • What regulatory pathways has the Rainbow CT followed, and what does this mean for its use in clinical practice?

    The Rainbow CT has undergone FDA 510(k) clearance and MDD authorization, classifying it as a Class II device. This means it has met regulatory standards for safety and performance, allowing it to be legally marketed and used in clinical practice for its intended purposes in dental and radiology settings.

  • How is the Rainbow CT supplied, and is it sterile upon delivery?

    The Rainbow CT is supplied as a reusable device and is not sterile upon delivery. Sterility is not applicable to this equipment, as it is designed for repeated use in clinical environments with proper cleaning and maintenance protocols.

Properties & raw data

Show properties, registry sources and raw records
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date
Other properties (19)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No

Sources (6)

  • FDA 510(k) K200271 24 fields · synced 22 Oct 2026
  • FDA UDI 08429df4-1498-4321-9668-a4190f43a19b 35 fields · synced 30 May 2026
  • FDA UDI 5236a1c3-1939-4ceb-ab0a-899c270d71b2 34 fields · synced 30 May 2026
  • EUDAMED 08809544906357|B-08809544906357 61 fields · synced 20 Jun 2026
  • EUDAMED 08809544906340|B-08809544906340 61 fields · synced 8 Jul 2026
  • EUDAMED 08809162708791|B-08809162708791 61 fields · synced 14 Jul 2026