FDA.report

510(k) K242239

Device
HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter))
Applicant
Gentuity, LLC
510(k) number
K242239
Product code
NQQ
Decision
Substantially Equivalent (SESE)
Decision date
2024-08-16
Date received
2024-07-30
Regulation
892.1560
Classification name
System, Imaging, Optical Coherence Tomography (Oct)
Medical specialty
Radiology
Review panel
Radiology
Device class
2
Clearance type
Special
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Edwin Rule
Address
142 N. Rd. Suite G Sudbury MA US 01776 01776

FDA Registration Numbers

Source Documents

510(k) summary PDF

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