FDA 510(k)
FDA class 2
Substantially Equivalent
🇰🇷 South Korea
rainbow MCT
K Number: K200270
·
Decision Apr 16, 2021
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
133
Applicant Total
4
Review Days
437
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- rainbow MCT
- K Number
- K200270
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Dentium Co., Ltd (Ict Branch)
- Date Received
- February 4, 2020
- Decision Date
- April 16, 2021
- Product Code
- OAS
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| OAS | X-Ray, Tomography, Computed, Dental | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (OAS), ordered by most recent decision date.
Dental X-ray System
FDA 510(k)
FDA Class 2
·Radiology
Dental Cone Beam Computed Tomography System
FDA 510(k)
FDA Class 2
·Radiology
medXion NEXUS
FDA 510(k)
FDA Class 2
·Radiology
RCT800
FDA 510(k)
FDA Class 2
·Radiology
Green X 12 VE (PHT-70CHS); Green X VE (PHT-70CHS)
FDA 510(k)
FDA Class 2
·Radiology
myray ProXIma X6
FDA 510(k)
FDA Class 2
·Radiology