FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
GE LOGIQ WORKS
K Number: K063006
·
Decision Nov 2, 2006
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
254
Review Days
31
Basic Information
- Device Name
- GE LOGIQ WORKS
- K Number
- K063006
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GENERAL ELECTRIC CO.
- Date Received
- October 2, 2006
- Decision Date
- November 2, 2006
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LLZ), ordered by most recent decision date.
CustomSurg OrthoPlanner
FDA 510(k)
FDA Class 2
·Radiology
uOmniscan
FDA 510(k)
FDA Class 2
·Radiology
Mosaic (V1.0.1)
FDA 510(k)
FDA Class 2
·Radiology
UroNav 4
FDA 510(k)
FDA Class 2
·Radiology
TechLive
FDA 510(k)
FDA Class 2
·Radiology
SMARTDent
FDA 510(k)
FDA Class 2
·Radiology
Other Clearances by GENERAL ELECTRIC CO.
| K Number | Device Name | ||
|---|---|---|---|
| K103489 | GE VEO RECONSTRUCTION OPTION | Sep 9, 2011 | Substantially Equivalent |
| K082317 | GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTION | Sep 26, 2008 | Substantially Equivalent |
| K081921 | GE VIVID E9 ULTRASOUND | Aug 6, 2008 | Substantially Equivalent |
| K073297 | GE LOGIQ P6 | Dec 18, 2007 | Substantially Equivalent |
| K072952 | GE ECHOPAC | Nov 16, 2007 | Substantially Equivalent |
| K072797 | GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUND | Oct 17, 2007 | Substantially Equivalent |
| K072075 | MODIFICATION TO GE LOGIQ A3 | Aug 29, 2007 | Substantially Equivalent |
| K071985 | GE VIVID S5 AND S6 DIAGNOSTIC ULTRASOUND | Aug 17, 2007 | Substantially Equivalent |
| K061682 | GE VOLUSON E8 ULTRASOUND SYSTEM | Jul 12, 2006 | Substantially Equivalent |
| K061525 | GE VIVID - I | Jul 3, 2006 | Substantially Equivalent |