Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)
FDA 510(k) K242098 · Shenzhen Vivolight Medical Device & Technology Co., Ltd.
510(k) numberK242098
Submission
- Device name
- Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)
- Applicant
- Shenzhen Vivolight Medical Device & Technology Co., Ltd.
Shenzhen, CN - Received
- July 18, 2024
- Decision date
- April 11, 2025
- 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.
Other 510(k)s with product code NQQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253459 | OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System…NQQ · Traditional | Abbott Medical | 04/24/2026SE |
| K251730 | LIA Console (542-7)NQQ · Traditional | Leadoptik, Inc. | 12/19/2025SE |
| K253101 | HyperVue Imaging System - IntegratedNQQ · Traditional | Spectrawave, Inc. | 12/15/2025SE |
| K252851 | deepLive (OSP12 + DMS)NQQ · Special | Damae Medical | 10/07/2025SE |
| K251198 | HyperVue SoftwareNQQ · Traditional | Spectrawave, Inc. | 07/16/2025SE |
| 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 |
| 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 |
| K240610 | deepLiveNQQ · Traditional | Damae Medical | 07/09/2024SE |
Questions and answers
When was Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2) cleared by the FDA?
Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2) (K242098) received a 510(k) decision of Substantially Equivalent on April 11, 2025, 267 days after the submission was received.
What is the product code of K242098?
The FDA product code is NQQ – System, Imaging, Optical Coherence Tomography (Oct), a Class II (moderate risk) device regulated under 21 CFR 892.1560.