HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter))
FDA 510(k) K242239 · Gentuity, LLC
510(k) numberK242239
Submission
- Device name
- HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter))
- Applicant
- Gentuity, LLC
Sudbury, MA, US - Received
- July 30, 2024
- Decision date
- August 16, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K253101 | HyperVue Imaging System - IntegratedNQQ · Traditional | Spectrawave, Inc. | 12/15/2025SE |
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| K250684 | OPUSWAVE Dual Sensor Imaging SystemNQQ · Traditional | Terumo Cardiovascular Systems Thi Plant | 07/02/2025SE |
| K242924 | OPXION Optical Skin Viewer (OPXSV1-01F)NQQ · Traditional | Opxion Technology, Inc. | 06/23/2025SE |
| 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 |
| K240610 | deepLiveNQQ · Traditional | Damae Medical | 07/09/2024SE |
More from Damae Medical
| 510(k) | Device | Decision |
|---|---|---|
| K242966 | Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging CatheterDQO · Traditional | 01/31/2025SE |
| K230620 | Gentuity® HF-OCT Imaging System with Vis-Rx® Micro-Imaging CatheterDQO · Traditional | 08/08/2023SE |
| K192922 | Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging CatheterNQQ · Traditional | 02/20/2020SE |
Questions and answers
When was HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter)) cleared by the FDA?
HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter)) (K242239) received a 510(k) decision of Substantially Equivalent on August 16, 2024, 17 days after the submission was received.
What is the product code of K242239?
The FDA product code is NQQ – System, Imaging, Optical Coherence Tomography (Oct), a Class II (moderate risk) device regulated under 21 CFR 892.1560.