FDA 510(k)
FDA class 2
Substantially Equivalent
🇨🇦 Canada
SONIX ULTRASOUND SCANNER
K Number: K093462
·
Decision Nov 20, 2009
Classifications
1
FEI Numbers
398
Registration Numbers
399
Same Product Code
408
Applicant Total
11
Review Days
14
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- SONIX ULTRASOUND SCANNER
- K Number
- K093462
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ultrasonix Medical Corporation
- Date Received
- November 6, 2009
- Decision Date
- November 20, 2009
- Product Code
- ITX
- 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 |
|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (ITX), ordered by most recent decision date.
ULTRASONIC PROBE UM-3R (UM-3R); ULTRASONIC PROBE UM-G20-29R (UM-G20-29R)
FDA 510(k)
FDA Class 2
·Radiology
ULTRASONIC PROBE UM-S20-17S (UM-S20-17S); ULTRASONIC PROBE UM-S20-20R (UM-S20-20R)
FDA 510(k)
FDA Class 2
·Radiology
Mendaera Guidance System
FDA 510(k)
FDA Class 2
·Radiology
Accuro® 3S Needle Guide Kit
FDA 510(k)
FDA Class 2
·Radiology
Ultrasound Transducer Cover
FDA 510(k)
FDA Class 2
·Radiology
UltraDrape UGPIV Barrier and Securement (34-15)
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by Ultrasonix Medical Corporation
| K Number | Device Name | ||
|---|---|---|---|
| K121812 | SONIXGPS | Dec 2, 2013 | Substantially Equivalent |
| K111818 | SONIXGPS NEEDLE SENSOR | Jun 13, 2012 | Substantially Equivalent |
| 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 |
| 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 |