510(k) K232386
K232386 is an FDA 510(k) premarket notification submitted by ABBOTT MEDICAL for the device "ILUMIEN OPTIS System, OPTIS Integrated System, OPTIS Mobile System, with AptiVue Imaging Software version E.6". The FDA issued a decision of Substantially Equivalent on September 8, 2023. The device falls under product code NQQ (System, Imaging, Optical Coherence Tomography (Oct)), a Class II device regulated under 21 CFR 892.1560. ABBOTT MEDICAL has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 8, 2023
- Date Received
- August 9, 2023
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Imaging, Optical Coherence Tomography (Oct)
- Device Class
- Class II
- Regulation Number
- 892.1560
- Review Panel
- SU
- Submission Type
This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging.