FDA.reportPublic FDA data

510(k) K232386

Device
ILUMIEN? OPTIS? System, OPTIS? Integrated System, OPTIS? Mobile System, with AptiVue? Imaging Software version E.6
Applicant
ABBOTT MEDICAL
510(k) number
K232386
Product code
NQQ
Decision
Substantially Equivalent (SESE)
Decision date
2023-09-08
Date received
2023-08-09
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
No

Applicant Contact#

Contact
Derek Pike
Address
4 Robbins Rd. Westford MA US 01886 01886

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code NQQ#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K253459OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)ABBOTT MEDICAL2026-04-24
K251730LIA Console (542-7)Leadoptik, Inc.2025-12-19
K253101HyperVue™ Imaging System - IntegratedSpectrawave, Inc.2025-12-15
K252851deepLive (OSP12 + DMS)Damae Medical2025-10-07
K251198HyperVue™ SoftwareSpectrawave, Inc.2025-07-16
K250684OPUSWAVE Dual Sensor Imaging SystemTerumo Cardiovascular Systems Thi Plant2025-07-02
K242924OPXION Optical Skin Viewer (OPXSV1-01F)Opxion Technology, Inc.2025-06-23
K242098Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)Shenzhen Vivolight Medical Device & Technology Co., Ltd.2025-04-11
K243016Starlight Imaging CatheterSpectrawave, Inc.2025-03-20
K242239HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter))Gentuity, LLC2024-08-16
K240610deepLiveDamae Medical2024-07-09
K230691HyperVue™ Imaging SystemSpectrawave, Inc.2023-06-07
K221257SpectraWAVE Imaging SystemSpectrawave, Inc.2023-02-28
K210458OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging SystemABBOTT MEDICAL2021-06-08
K203578OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography SystemPerimeter Medical Imaging Ai, Inc.2021-02-25