FDA 510(k)
FDA class 2
Substantially Equivalent
🇳🇴 Norway
GE ECHOPAC
K Number: K131685
·
Decision Sep 24, 2013
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
10
Review Days
106
Basic Information
- Device Name
- GE ECHOPAC
- K Number
- K131685
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GE VINGMED ULTRASOUND AS
- Date Received
- June 10, 2013
- Decision Date
- September 24, 2013
- Product Code
- LLZ
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | FDA class 2 | Radiology |
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| K120201 | GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM | Apr 19, 2012 | 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 |