← Back to catalogue
HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console),…
FDA 510(k)Class II (US FDA 510(k))
510(k) K242239
Identifiers
- 510(k) Number
- K242239 FDA 510(k)
- FDA Product Code
- NQQ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1560 FDA 510(k)
- Regulation Number
- 892.1560 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console),… by Gentuity, LLC — Class II — FDA_510K — listed in FDA 510(k)
Authorization Coverage (1 country)
Regulatory Authorizations
United States Active
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K242239 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Gentuity, LLC
Sources (1)
- FDA 510(k) K242239 24 fields · synced Jun 18, 2026