FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIGITAL X-RAY IMAGING SYSTEM (PAX-PRIMO) MODEL PAX-PRIMO
K Number: K100317
·
Decision Mar 24, 2010
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
205
Applicant Total
40
Review Days
48
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Basic Information
- Device Name
- DIGITAL X-RAY IMAGING SYSTEM (PAX-PRIMO) MODEL PAX-PRIMO
- K Number
- K100317
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- VATECH Co., Ltd.
- Date Received
- February 4, 2010
- Decision Date
- March 24, 2010
- Product Code
- MUH
- 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 |
|---|---|---|---|
| MUH | System, X-Ray, Extraoral Source, Digital | FDA class 2 | Dental |
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