Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter
FDA 510(k) clearance K242966 · decided 2025-01-31
Clearance details
- K-number
- K242966
- Device name
- Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter
- Applicant
- Gentuity, LLC
- Decision
- Substantially Equivalent
- Date received
- 2024-09-26
- Decision date
- 2025-01-31
- Days to decision
- 127 days
- Clearance type
- Traditional
- Product code
- DQO
- Device class
- 2
- Regulation number
- 870.1200
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Sudbury, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Gentuity HF-OCT Imaging System Model G10-01; Software version 23.2.13; recall (Z-1823-2026) | Gentuity, LLC | 2026-04-16 |