510(k) K242098 ยท NQQ System, Imaging, Optical Coherence Tomography (Oct)
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 |
| Decision | Substantially Equivalent, Apr 11, 2025 |
| Received | Jul 18, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K242098
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.