FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
syngo.CT Lung CAD
K Number: K193216
·
Decision Mar 9, 2020
Classifications
1
FEI Numbers
11
Registration Numbers
11
Same Product Code
19
Applicant Total
32
Review Days
109
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Basic Information
- Device Name
- syngo.CT Lung CAD
- K Number
- K193216
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Siemens Medi Cal Solutions, Inc.
- Date Received
- November 21, 2019
- Decision Date
- March 9, 2020
- 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 |
Similar 510(k) Clearances
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AVIEW Lung Nodule CAD
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