syngo.CT Lung CAD— 510(k) K193216
Substantially EquivalentSiemens Medi Cal Solutions, Inc.
FDA 510(k) clearance K193216 for syngo.CT Lung CAD, Substantially Equivalent on 2020-03-09. Applicant: Siemens Medi Cal Solutions, Inc.. Device class: 2.
Clearance details
- Applicant
- Siemens Medi Cal Solutions, Inc.
- Product code
- Code OEB
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Malvern, PA, US
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