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FDA 510(k)

rainbow CT

K-Number: K200271 · 2021-04-16

ApplicantDentium Co., Ltd (Ict Branch)
Decision Date2021-04-16
Product CodeOAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

rainbow CT is the device name listed in this FDA 510(k) record. The listed applicant is Dentium Co., Ltd (Ict Branch). It received FDA 510(k) clearance on 2021-04-16 under 510(k) number K200271. The device is classified under product code OAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the rainbow CT?

rainbow CT is a medical device that received FDA 510(k) clearance on 2021-04-16. The listed applicant is Dentium Co., Ltd (Ict Branch). The 510(k) number is K200271.

When did rainbow CT receive FDA 510(k) clearance?

rainbow CT received FDA 510(k) clearance on 2021-04-16, under 510(k) number K200271.

Who is the listed applicant for rainbow CT?

The FDA 510(k) record lists Dentium Co., Ltd (Ict Branch) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for rainbow CT?

The FDA product code for rainbow CT is OAS.

Other records listing Dentium Co., Ltd (Ict Branch) as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K231181bright CTK200270rainbow MCTK201247Intraoral Sensor

Related Devices (Code: OAS)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261748Dental Cone-beam Computed Tomography (mDX-15P Series)Hefei Meyer Optoelectronic Technology, Inc.K250839Dental X-ray SystemChangzhou Boen Zhongding Medical Technology Co., Ltd.K260662Dental Cone Beam Computed Tomography SystemYofo Medical Technology Co., Ltd.K253935medXion NEXUSmedXion Technologies, Inc.K260462RCT800Ray Co., Ltd.K260093Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)VATECH Co., Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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