FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
XELERIS 3 PROCESSING AND REVIEW WORKSTATION
K Number: K093982
·
Decision Jan 8, 2010
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
17
Review Days
15
Basic Information
- Device Name
- XELERIS 3 PROCESSING AND REVIEW WORKSTATION
- K Number
- K093982
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GE MEDICAL SYSTEMS F.I. HAIFA
- Date Received
- December 24, 2009
- Decision Date
- January 8, 2010
- Product Code
- LLZ
- 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 |
|---|---|---|---|
| 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 GE MEDICAL SYSTEMS F.I. HAIFA
| K Number | Device Name | ||
|---|---|---|---|
| K130884 | XELERIS 3.1 PROCESSING AND REVIEW WORKSTATION | Apr 12, 2013 | Substantially Equivalent |
| K093514 | DISCOVERY MODEL NM/CT 670 | Dec 10, 2009 | Substantially Equivalent |
| K083504 | GE DISCOVERY NM/CT 570C | Dec 12, 2008 | Substantially Equivalent |
| K080124 | VENTRI 1.1 | Jan 31, 2008 | Substantially Equivalent |
| K051855 | VENTRI | Aug 2, 2005 | Substantially Equivalent |
| K043381 | INFINIA LIGHTSPEED | Dec 23, 2004 | Substantially Equivalent |
| K033874 | MYOLIGHT | Dec 30, 2003 | Substantially Equivalent |
| K023932 | GE PHOTON ENERGY RECOVERY (PER) OPTION | Dec 11, 2002 | Substantially Equivalent |
| K022960 | GE QUASAR NUCLEAR MEDICINE SYSTEM | Sep 19, 2002 | Substantially Equivalent |
| K003264 | QPS/BPGS/MOCO PROCESSING APPLICATIONS FOR ENTEGRA WORKSTATION | Dec 21, 2000 | Substantially Equivalent |