Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter— 510(k) K192922
Substantially EquivalentGentuity, LLC
FDA 510(k) clearance K192922 for Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter, Substantially Equivalent on 2020-02-20. Applicant: Gentuity, LLC. Device class: 2.
Clearance details
- Applicant
- Gentuity, LLC
- Product code
- Code NQQ
- Device class
- Class 2
- Regulation
- 21 CFR 892.1560
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Sudbury, MA, US
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