FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
SONIXGPS NEEDLE SENSOR
K Number: K111818
·
Decision Jun 13, 2012
Classifications
1
FEI Numbers
348
Registration Numbers
349
Same Product Code
892
Applicant Total
11
Review Days
351
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Basic Information
- Device Name
- SONIXGPS NEEDLE SENSOR
- K Number
- K111818
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ultrasonix Medical Corporation
- Date Received
- June 28, 2011
- Decision Date
- June 13, 2012
- Product Code
- IYO
- 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | FDA class 2 | Radiology |
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Other Clearances by Ultrasonix Medical Corporation
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|---|---|---|---|
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| K093462 | SONIX ULTRASOUND SCANNER | Nov 20, 2009 | Substantially Equivalent |
| K083095 | SONIXTOUCH ULTRASOUND SYSTEM | Oct 31, 2008 | 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 |