FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALLURA 3D-CA, RELEASE 1
K Number: K042334
·
Decision Sep 27, 2004
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
24
Review Days
28
Basic Information
- Device Name
- ALLURA 3D-CA, RELEASE 1
- K Number
- K042334
- 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 NORTH AMERICA CO.
- Date Received
- August 30, 2004
- Decision Date
- September 27, 2004
- 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 PHILIPS MEDICAL SYSTEMS NORTH AMERICA CO.
| K Number | Device Name | ||
|---|---|---|---|
| K101311 | EP NAVIGATOR R3 | Sep 30, 2010 | Substantially Equivalent |
| K090625 | WIRELESS PORTABLE DETECTOR FD-W17 | Mar 24, 2009 | Substantially Equivalent |
| K090590 | VERADIUS, MODEL 718-130 | Mar 16, 2009 | Substantially Equivalent |
| K082280 | SURESIGNS VS2 VITAL SIGNS MONITOR, SURESIGNS VM1 PATIENT MONITOR, SURESIGNS VS3 CITAL SIGNS MONITOR | Oct 8, 2008 | Substantially Equivalent |
| K063781 | PHILIPS XD-S DIRECT RADIOGRAPHY WORKSTATION/PACKAGE | Jan 5, 2007 | Substantially Equivalent |
| K062268 | MASIMO SET SPO2 MODULE FOR PHILIPS AND M3001A MULTI-MEASUREMENT SERVER OPTION A03 | Oct 18, 2006 | Substantially Equivalent |
| K061685 | PULSERA | Sep 15, 2006 | Substantially Equivalent |
| K061995 | XCELERA | Sep 6, 2006 | Substantially Equivalent |
| K060749 | XPERCT | Apr 4, 2006 | Substantially Equivalent |
| K050692 | FLXIS | Apr 8, 2005 | Substantially Equivalent |