NQQ · System, Imaging, Optical Coherence Tomography (Oct)
Radiology · 21 CFR 892.1560 · Class 2
Overview
| Product Code | NQQ |
|---|---|
| Device Name | System, Imaging, Optical Coherence Tomography (Oct) |
| Regulation | 21 CFR 892.1560 |
| Device Class | Class 2 |
| Review Panel | Radiology |
| 3rd-Party Reviewable | Yes |
Identification
An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Classification Rationale
Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Special Controls
*Classification.* Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
Recent Cleared Devices (20 of 45)
Showing 20 most recent of 45 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K251730 | LIA Console (542-7) | Leadoptik, Inc. | Dec 19, 2025 | SESE |
| K253101 | HyperVue Imaging System - Integrated | Spectrawave, Inc. | Dec 15, 2025 | SESE |
| K252851 | deepLive (OSP12 + DMS) | Damae Medical | Oct 7, 2025 | SESE |
| K251198 | HyperVue Software | Spectrawave, Inc. | Jul 16, 2025 | SESE |
| K250684 | OPUSWAVE Dual Sensor Imaging System | Terumo Cardiovascular Systems Thi Plant | Jul 2, 2025 | SESE |
| K242924 | OPXION Optical Skin Viewer (OPXSV1-01F) | Opxion Technology, Inc. | Jun 23, 2025 | SESE |
| K242098 | Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2) | Shenzhen Vivolight Medical Device & Technology Co., Ltd. | Apr 11, 2025 | SESE |
| K243016 | Starlight Imaging Catheter | Spectrawave, Inc. | Mar 20, 2025 | SESE |
| K242239 | HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter)) | Gentuity, LLC | Aug 16, 2024 | SESE |
| K240610 | deepLive | Damae Medical | Jul 9, 2024 | SESE |
| K232386 | ILUMIEN OPTIS System, OPTIS Integrated System, OPTIS Mobile System, with AptiVue Imaging Software version E.6 | ABBOTT MEDICAL | Sep 8, 2023 | SESE |
| K230691 | HyperVue Imaging System | Spectrawave, Inc. | Jun 7, 2023 | SESE |
| K221257 | SpectraWAVE Imaging System | Spectrawave, Inc. | Feb 28, 2023 | SESE |
| K210458 | OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System | ABBOTT MEDICAL | Jun 8, 2021 | SESE |
| K203578 | OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System | Perimeter Medical Imaging Ai, Inc. | Feb 25, 2021 | SESE |
| K201552 | ApolloVue S100 Image System | Apollo Medical Optics, Ltd. | Sep 2, 2020 | SESE |
| K192922 | Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter | Gentuity, LLC | Feb 20, 2020 | SESE |
| K191117 | NvisionVLE Low-profile Optical Probe | Ninepoint Medical, Inc. | Jul 19, 2019 | SESU |
| K183320 | Ilumien Optis, Optis Integrated, Optis Mobile | St. Jude Medical (Now Abbott Medical) | Apr 2, 2019 | SESE |
| K190404 | OTIS Optical Coherence Tomography SYstem | Perimeter Medical Imaging, Inc. | Mar 26, 2019 | SESE |
Top Applicants
- Lightlab Imaging, Inc. — 8 clearances
- Ninepoint Medical, Inc. — 8 clearances
- Spectrawave, Inc. — 5 clearances
- Perimeter Medical Imaging, Inc. — 3 clearances
- ABBOTT MEDICAL — 2 clearances
