Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter
FDA 510(k) K192922 · Gentuity, LLC
510(k) numberK192922
Submission
- Device name
- Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter
- Applicant
- Gentuity, LLC
Sudbury, MA, US - Received
- October 16, 2019
- Decision date
- February 20, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NQQ – System, Imaging, Optical Coherence Tomography (Oct)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.1560
- Specialty
- Radiology
This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging.
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| K242098 | Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System…NQQ · Traditional | Shenzhen Vivolight Medical Device & Technology… | 04/11/2025SE |
| K243016 | Starlight Imaging CatheterNQQ · Special | Spectrawave, Inc. | 03/20/2025SE |
| K242239 | HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30…NQQ · Special | Gentuity, LLC | 08/16/2024SE |
More from Gentuity, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K242966 | Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterDQO · Traditional | 01/31/2025SE |
| K242239 | HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30…NQQ · Special | 08/16/2024SE |
| K230620 | Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging CatheterDQO · Traditional | 08/08/2023SE |
Questions and answers
When was Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter cleared by the FDA?
Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter (K192922) received a 510(k) decision of Substantially Equivalent on February 20, 2020, 127 days after the submission was received.
What is the product code of K192922?
The FDA product code is NQQ – System, Imaging, Optical Coherence Tomography (Oct), a Class II (moderate risk) device regulated under 21 CFR 892.1560.