FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
CS 8100 3D
K Number: K133406
·
Decision Mar 14, 2014
Classifications
1
FEI Numbers
46
Registration Numbers
46
Same Product Code
133
Applicant Total
15
Review Days
128
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Basic Information
- Device Name
- CS 8100 3D
- K Number
- K133406
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Trophy
- Date Received
- November 6, 2013
- Decision Date
- March 14, 2014
- 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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Other Clearances by Trophy
| K Number | Device Name | ||
|---|---|---|---|
| K193390 | CS Model+ | Apr 2, 2020 | Substantially Equivalent |
| K200183 | CS 9600 | Mar 13, 2020 | Substantially Equivalent |
| K181136 | CS 9600 | May 24, 2018 | Substantially Equivalent |
| K173622 | CS Imaging | Jan 16, 2018 | Substantially Equivalent |
| K151087 | CS 8100SC, CS8100SC Access | Aug 21, 2015 | Substantially Equivalent |
| K151837 | CS 3D Imaging | Aug 19, 2015 | Substantially Equivalent |
| K141607 | DENTAL IMAGING SOFTWARE | Sep 18, 2014 | Substantially Equivalent |
| K120975 | CS 8100 CS 8100 ACCESS | Jun 22, 2012 | Substantially Equivalent |
| K113419 | CS IMAGING | Feb 16, 2012 | Substantially Equivalent |
| K103659 | CS 9300, CS 9300C | Aug 18, 2011 | Substantially Equivalent |