FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EPI-SCOPE OPTION FOR Q SERIES CT SYSTEMS
K Number: K962010
·
Decision Mar 21, 1997
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
181
Review Days
302
Basic Information
- Device Name
- EPI-SCOPE OPTION FOR Q SERIES CT SYSTEMS
- K Number
- K962010
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
- Date Received
- May 23, 1996
- Decision Date
- March 21, 1997
- 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 PHILIPS MEDICAL SYSTEMS(CLEVELAND), INC.
| K Number | Device Name | ||
|---|---|---|---|
| K130992 | PINNACLE3 RADIATION THERAPY PLANNING SYSTEM | Jun 14, 2013 | Substantially Equivalent |
| K092747 | PHILIPS COMPREHENSIVE CARDIAC ANALYSIS (CCA) - PLAQUE ASSESSMENT TOOL | Oct 9, 2009 | Substantially Equivalent |
| K090462 | BRILLIANCE DUAL ENERGY OPTION | Jun 23, 2009 | Substantially Equivalent |
| K091195 | PHILIPS MX 16 SLICE CT SYSTEM PHASE11, MODEL 9896 056 56511 | May 27, 2009 | Substantially Equivalent |
| K090403 | AUTOSPECT | Mar 31, 2009 | Substantially Equivalent |
| K083498 | PHILIPS MODEL MX 16 SLICE CT SYSTEM | Dec 17, 2008 | Substantially Equivalent |
| K081426 | NEXSTAR LIFTOFF PET APPLICATION SOFTWARE SUITE | Jun 4, 2008 | Substantially Equivalent |
| K081135 | GEMINI CONDOR | Apr 29, 2008 | Substantially Equivalent |
| K080927 | BRIGHTVIEW VCT IMAGING SYSTEM | Apr 11, 2008 | Substantially Equivalent |
| K060937 | BRILLIANCE VOLUME | Jun 5, 2006 | Substantially Equivalent |