FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
COLONCAD API 3.1
K Number: K083423
·
Decision May 17, 2011
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
3
Applicant Total
1
Review Days
909
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Basic Information
- Device Name
- COLONCAD API 3.1
- K Number
- K083423
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medicsight Plc
- Date Received
- November 19, 2008
- Decision Date
- May 17, 2011
- Product Code
- NWE
- 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 |
|---|---|---|---|
| NWE | Colon Computed Tomography System, Computer Aided Detection | FDA class 2 | Radiology |
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