FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
SONIXTOUCH ULTRASOUND SYSTEM
K Number: K083095
·
Decision Oct 31, 2008
Classifications
1
FEI Numbers
220
Registration Numbers
220
Same Product Code
1171
Applicant Total
11
Review Days
14
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Basic Information
- Device Name
- SONIXTOUCH ULTRASOUND SYSTEM
- K Number
- K083095
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1550
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ultrasonix Medical Corporation
- Date Received
- October 17, 2008
- Decision Date
- October 31, 2008
- Product Code
- IYN
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| IYN | System, Imaging, Pulsed Doppler, Ultrasonic | FDA class 2 | Radiology |
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FDA Class 2
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Other Clearances by Ultrasonix Medical Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K121812 | SONIXGPS | Dec 2, 2013 | Substantially Equivalent |
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| K113663 | SONIXTABLET ULTRASOUND SCANNER | Jan 25, 2012 | Substantially Equivalent |
| K112726 | SONIX ULTRASOUND SCANNER | Sep 27, 2011 | Substantially Equivalent |
| K102997 | SONIXTABLET ULTRASOUND SCANNER | Dec 21, 2010 | Substantially Equivalent |
| K093462 | SONIX ULTRASOUND SCANNER | Nov 20, 2009 | Substantially Equivalent |
| K080935 | SONIX MDP ULTRASOUND SCANNER | Aug 6, 2008 | Substantially Equivalent |
| K061827 | SONIX ULTRASOUND SCANNER | Aug 4, 2006 | Substantially Equivalent |
| K042326 | ERGOSONIX ULTRASOUND SCANNER, MODULO ULTRASOUND SCANNER | Sep 16, 2004 | Substantially Equivalent |
| K020630 | ULTRASONIX ERGOSONIX 500 ULTRASOUND SCANNER | Jun 13, 2002 | Substantially Equivalent |