Chrysalis Intelligence · Product Codes · NQQ

NQQ · System, Imaging, Optical Coherence Tomography (Oct)

Radiology · 18 clearances · 10 unique sponsors

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Device class
Class II
Regulation 892.1560
Total clearances
18
2020-02-20 → 2026-04-24
Last 12 months
4
Unique sponsors
10
Definition

What is System, Imaging, Optical Coherence Tomography (Oct)

This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging.
Classification details
Medical specialty
Radiology
Review panel
SU
Regulation number
892.1560
Implant
N
Life-sustain / support
N
GMP exempt
N
Third-party review
Y
Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor Clearances Last 12 mo Most recent
Spectrawave, Inc. 5 1 2025-12-15
ABBOTT MEDICAL 3 1 2026-04-24
Gentuity, LLC 2 0 2024-08-16
Damae Medical 2 1 2025-10-07
Perimeter Medical Imaging Ai, Inc. 1 0 2021-02-25
Leadoptik, Inc. 1 1 2025-12-19
Apollo Medical Optics, Ltd. 1 0 2020-09-02
Shenzhen Vivolight Medical Device & Technology Co., Ltd. 1 0 2025-04-11
Terumo Cardiovascular Systems Thi Plant 1 0 2025-07-02
Opxion Technology, Inc. 1 0 2025-06-23
Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

CodeTypeDescriptionConfidenceRationale
92134 CPT — High Optical coherence tomography (OCT) of macula or optic nerve head; most specific OCT billing code
92004 CPT — Medium Comprehensive eye exam; OCT imaging commonly billed under ophthalmic codes
Pulse

Most recent 510(k) clearances

DateK-numberSponsorDevice
2026-04-24 K253459 ABBOTT MEDICAL OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)
2025-12-19 K251730 Leadoptik, Inc. LIA Console (542-7)
2025-12-15 K253101 Spectrawave, Inc. HyperVue™ Imaging System - Integrated
2025-10-07 K252851 Damae Medical deepLive (OSP12 + DMS)
2025-07-16 K251198 Spectrawave, Inc. HyperVue™ Software
2025-07-02 K250684 Terumo Cardiovascular Systems Thi Plant OPUSWAVE Dual Sensor Imaging System
2025-06-23 K242924 Opxion Technology, Inc. OPXION Optical Skin Viewer (OPXSV1-01F)
2025-04-11 K242098 Shenzhen Vivolight Medical Device & Technology Co., Ltd. Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2)
2025-03-20 K243016 Spectrawave, Inc. Starlight Imaging Catheter
2024-08-16 K242239 Gentuity, LLC HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter))
2024-07-09 K240610 Damae Medical deepLive
2023-09-08 K232386 ABBOTT MEDICAL ILUMIEN™ OPTIS™ System, OPTIS™ Integrated System, OPTIS™ Mobile System, with AptiVue™ Imaging Software version E.6
2023-06-07 K230691 Spectrawave, Inc. HyperVue™ Imaging System
2023-02-28 K221257 Spectrawave, Inc. SpectraWAVE Imaging System
2021-06-08 K210458 ABBOTT MEDICAL OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System
2021-02-25 K203578 Perimeter Medical Imaging Ai, Inc. OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System
2020-09-02 K201552 Apollo Medical Optics, Ltd. ApolloVue S100 Image System
2020-02-20 K192922 Gentuity, LLC Gentuity HF-OCT Imaging System with Vis-Rx Micro-Imaging Catheter
Data source: openFDA · Generated 2026-08-28 09:16 · Last ingest 2026-08-28T13:16:47.116226 · Pipeline: Chrysalis Intelligence