FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OPTEO, VIDEOGRAPH HD
K Number: K133271
·
Decision Apr 28, 2014
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
205
Applicant Total
6
Review Days
186
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Basic Information
- Device Name
- OPTEO, VIDEOGRAPH HD
- K Number
- K133271
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Owandy
- Date Received
- October 24, 2013
- Decision Date
- April 28, 2014
- 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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Other Clearances by Owandy
| K Number | Device Name | ||
|---|---|---|---|
| K130443 | I-MAX TOUCH 3D | Jun 14, 2013 | Substantially Equivalent |
| K093105 | VISTEO | Oct 18, 2010 | Substantially Equivalent |
| K083057 | I-MAX TOUCH | Jun 2, 2009 | Substantially Equivalent |
| K070505 | KRYSTAL-X WIFI | Apr 5, 2007 | Substantially Equivalent |
| K062403 | IMAX CEPH DIGITAL X-RAY SENSOR | Nov 14, 2006 | Substantially Equivalent |