FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇳 India
Intraskan DC Plus
K Number: K170967
·
Decision Jun 8, 2017
Classifications
1
FEI Numbers
60
Registration Numbers
60
Same Product Code
189
Applicant Total
4
Review Days
69
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
- Intraskan DC Plus
- K Number
- K170967
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Skanray Technologies Private Limited
- Date Received
- March 31, 2017
- Decision Date
- June 8, 2017
- Product Code
- EHD
- Advisory Committee
- Dental
- 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 |
|---|---|---|---|
| EHD | Unit, X-Ray, Extraoral With Timer | FDA class 2 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EHD), ordered by most recent decision date.
Portable Dental X-ray System Model PDX nova
FDA 510(k)
FDA Class 2
·Dental
NOMAD Pro 3
FDA 510(k)
FDA Class 2
·Dental
Dental X-RAY Unit (AJX200)
FDA 510(k)
FDA Class 2
·Dental
Portable Dental X-ray Device (GT-1)
FDA 510(k)
FDA Class 2
·Dental
Diagnostic X-Ray Equipment Model POCT22
FDA 510(k)
FDA Class 2
·Dental
Dental X-Ray Device (Ai Ray Lite, Ai Ray Pro, Master Ray )
FDA 510(k)
FDA Class 2
·Dental