FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
CS 3D Imaging
K Number: K151837
·
Decision Aug 19, 2015
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
11
Review Days
44
Basic Information
- Device Name
- CS 3D Imaging
- K Number
- K151837
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- TROPHY
- Date Received
- July 6, 2015
- Decision Date
- August 19, 2015
- Product Code
- LLZ
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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| K080889 | KODAK 9000C EXTRAORAL IMAGING SYSTEM | Apr 29, 2008 | Substantially Equivalent |
| K073435 | KODAK 9000, KODAK 9000 3D | Feb 11, 2008 | Substantially Equivalent |