FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇬 Singapore
DEXTROSCOPE, MODEL MK10; DEXTROBEAM, MODEL MK3, MK4; RADIODEXTER, MODEL 1.0
K Number: K063730
·
Decision Jan 31, 2007
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
5
Review Days
44
Basic Information
- Device Name
- DEXTROSCOPE, MODEL MK10; DEXTROBEAM, MODEL MK3, MK4; RADIODEXTER, MODEL 1.0
- K Number
- K063730
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- VOLUME INTERACTIONS PTE LTD
- Date Received
- December 18, 2006
- Decision Date
- January 31, 2007
- 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 VOLUME INTERACTIONS PTE LTD
| K Number | Device Name | ||
|---|---|---|---|
| K071054 | RADIODEXTER, DEXTROSCOPE, DEXTROBEAM, MODELS 1.0, MK10, MK3 & MK4 | May 22, 2007 | Substantially Equivalent |
| K053162 | DEXTROSCOPE & DEXTROBEAM | Dec 9, 2005 | Substantially Equivalent |
| K032924 | RADIODEXTER VERSION 1.0, DEXTROSCOPE, MODEL MK10 AND DEXTROBEAM, MODEL MK3 | Oct 10, 2003 | Substantially Equivalent |
| K022938 | VIZDEXTER VERSION 2.0; DEXTROSCOPE MK8; DEXTROBEAM MK3 | Oct 25, 2002 | Substantially Equivalent |