FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
QUANTUM/ CANON CXDI INTEGRATION SYSTEM, MODEL QG-DIG-CXDI
K Number: K080905
·
Decision Jul 16, 2008
Classifications
1
FEI Numbers
599
Registration Numbers
599
Same Product Code
2271
Applicant Total
5
Review Days
106
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Basic Information
- Device Name
- QUANTUM/ CANON CXDI INTEGRATION SYSTEM, MODEL QG-DIG-CXDI
- K Number
- K080905
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Quantum Medical Imaging, LLC
- Date Received
- April 1, 2008
- Decision Date
- July 16, 2008
- 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 Quantum Medical Imaging, LLC
| K Number | Device Name | ||
|---|---|---|---|
| K083181 | QV-9000 UNIVERSAL SYSTEM | Nov 26, 2008 | Substantially Equivalent |
| K072010 | QUANTUM DIREX SYSTEM | Aug 7, 2007 | Substantially Equivalent |
| K023008 | UNIVERSAL SYSTEM, MODEL QV-800 | Nov 13, 2002 | Substantially Equivalent |
| K011486 | Q-RAD RADIOGRAPHIC SYSTEM | Jun 20, 2001 | Substantially Equivalent |