FDA 510(k)
FDA class 2
Substantially Equivalent
🇸🇬 Singapore
RADIODEXTER VERSION 1.0, DEXTROSCOPE, MODEL MK10 AND DEXTROBEAM, MODEL MK3
K Number: K032924
·
Decision Oct 10, 2003
Classifications
1
FEI Numbers
609
Registration Numbers
609
Same Product Code
2221
Applicant Total
5
Review Days
18
Basic Information
- Device Name
- RADIODEXTER VERSION 1.0, DEXTROSCOPE, MODEL MK10 AND DEXTROBEAM, MODEL MK3
- K Number
- K032924
- 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
- September 22, 2003
- Decision Date
- October 10, 2003
- 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 |
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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 |
| K063730 | DEXTROSCOPE, MODEL MK10; DEXTROBEAM, MODEL MK3, MK4; RADIODEXTER, MODEL 1.0 | Jan 31, 2007 | Substantially Equivalent |
| K053162 | DEXTROSCOPE & DEXTROBEAM | Dec 9, 2005 | Substantially Equivalent |
| K022938 | VIZDEXTER VERSION 2.0; DEXTROSCOPE MK8; DEXTROBEAM MK3 | Oct 25, 2002 | Substantially Equivalent |