FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
LUNG CAR 1.1
K Number: K041807
·
Decision Jul 22, 2004
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
19
Applicant Total
5
Review Days
16
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Basic Information
- Device Name
- LUNG CAR 1.1
- K Number
- K041807
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Medicsight
- Date Received
- July 6, 2004
- Decision Date
- July 22, 2004
- Product Code
- OEB
- 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 |
|---|---|---|---|
| OEB | Lung Computed Tomography System, Computer-Aided Detection | FDA class 2 | Radiology |
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