CT Cardiomegaly— 510(k) K232613
Substantially EquivalentInnolitics, LLC
FDA 510(k) clearance K232613 for CT Cardiomegaly, Substantially Equivalent on 2024-02-28. Applicant: Innolitics, LLC. Device class: 2.
Clearance details
- Applicant
- Innolitics, LLC
- Product code
- Code QIH
- Device class
- Class 2
- Regulation
- 21 CFR 892.2050
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Austin, TX, US
Recent devices under product code QIH
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