FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
CS 9300, CS 9300C
K Number: K103659
·
Decision Aug 18, 2011
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
133
Applicant Total
15
Review Days
246
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Basic Information
- Device Name
- CS 9300, CS 9300C
- K Number
- K103659
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Trophy
- Date Received
- December 15, 2010
- Decision Date
- August 18, 2011
- 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 |
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| K141607 | DENTAL IMAGING SOFTWARE | Sep 18, 2014 | Substantially Equivalent |
| K133406 | CS 8100 3D | Mar 14, 2014 | Substantially Equivalent |
| K120975 | CS 8100 CS 8100 ACCESS | Jun 22, 2012 | Substantially Equivalent |
| K113419 | CS IMAGING | Feb 16, 2012 | Substantially Equivalent |