FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
K Number: K120201
·
Decision Apr 19, 2012
Classifications
1
FEI Numbers
348
Registration Numbers
349
Same Product Code
892
Applicant Total
10
Review Days
87
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Basic Information
- Device Name
- GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM
- K Number
- K120201
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Ge Vingmed Ultrasound AS
- Date Received
- January 23, 2012
- Decision Date
- April 19, 2012
- Product Code
- IYO
- Advisory Committee
- Radiology
- 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 |
|---|---|---|---|
| IYO | System, Imaging, Pulsed Echo, Ultrasonic | FDA class 2 | Radiology |
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Other Clearances by Ge Vingmed Ultrasound AS
| K Number | Device Name | ||
|---|---|---|---|
| K150087 | Vivid E80 Diagnostic Ultrasound Imaging System, Vivid E90 Diagnostic Ultrasound Imaging System, Vivid E95 Diagnostic Ultrasound Imaging System | Mar 4, 2015 | Substantially Equivalent |
| K150085 | GE EchoPAC | Mar 2, 2015 | Substantially Equivalent |
| K141093 | 6VT-D ULTRASOUND TRANSDUCER | May 15, 2014 | Substantially Equivalent |
| K131685 | GE ECHOPAC | Sep 24, 2013 | Substantially Equivalent |
| K131514 | GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM | Jul 12, 2013 | Substantially Equivalent |
| K123894 | GE ECHOPAC | Jan 29, 2013 | Substantially Equivalent |
| K101149 | GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM | Oct 13, 2010 | Substantially Equivalent |
| K101324 | GE ECHOPAC MODEL BT10 | Oct 5, 2010 | Substantially Equivalent |
| K092756 | GE VSCAN COMPACT DIAGNOSTIC ULTRASOUND SYSTEM | Sep 28, 2009 | Substantially Equivalent |