FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSOR
K Number: K090526
·
Decision Dec 2, 2009
Classifications
1
FEI Numbers
87
Registration Numbers
87
Same Product Code
205
Applicant Total
7
Review Days
279
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Basic Information
- Device Name
- MEDICAL IMAGE PROCESSING UNIT, MODEL EZSENSOR
- K Number
- K090526
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 872.1800
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- E-Woo Technology
- Date Received
- February 26, 2009
- Decision Date
- December 2, 2009
- 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 E-Woo Technology
| K Number | Device Name | ||
|---|---|---|---|
| K091090 | DIGITAL FLAT PANEL X-RAY DETECTOR, MODEL XMARU 1717 | Aug 9, 2010 | Substantially Equivalent |
| K090991 | COMPUTED TOMOGRAPHY X-RAY SYSTEM, MODEL PICASSO-DUO | Oct 9, 2009 | Substantially Equivalent |
| K090171 | COMPUTED TOMOGRAPHY X-RAY SYSTEM, PAX-REVE3D | Apr 30, 2009 | Substantially Equivalent |
| K082410 | MASTER3DS | Oct 31, 2008 | Substantially Equivalent |
| K081847 | PICASSO MASTER, ECT AND MASTER 3D | Aug 21, 2008 | Substantially Equivalent |
| K070658 | DENTAL DIGITAL PANORAMIC/3D IMAGING SYSTEM | Apr 5, 2007 | Substantially Equivalent |