510(k) K253459
- Device
- OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001)
- Applicant
- ABBOTT MEDICAL
- 510(k) number
- K253459
- Product code
- NQQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2026-04-24
- Date received
- 2025-10-07
- Regulation
- 892.1560
- Classification name
- System, Imaging, Optical Coherence Tomography (Oct)
- Medical specialty
- Radiology
- Review panel
- Radiology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
- Source
- FDA openFDA 510(k) dataset plus migrated FDA.report data
Related Records
Applicant Contact
- Contact
- Derek Pike
- Address
- 4 Robbins Rd. Westford MA US 01886 01886
FDA Registration Numbers
- 3042929028
- 3004091615
- 2024311
- 3013276158
- 2245304
- 3012179728
- 3043527620
- 3010126772
- 3004837686
- 2030624
- 3013440400
- 3017654247
- 3027259266
- 3042970803
- 3007603861
- 3013351723
- 3011578544
- 3038165043
- 3012198618
- 1220477
- 1221051
- 3005228872
- 2024168
- 2246552
- 3009882464
- 3021630097
- 3009600098
Source Documents
FDA 510(k) Premarket Notification Database · 510(k) summary PDF · openFDA JSON
Other 510(k) Records For Product Code NQQ
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K251730 | LIA Console (542-7) | Leadoptik, Inc. | 2025-12-19 |
| K253101 | HyperVue Imaging System - Integrated | Spectrawave, Inc. | 2025-12-15 |
| K252851 | deepLive (OSP12 + DMS) | Damae Medical | 2025-10-07 |
| K251198 | HyperVue Software | Spectrawave, Inc. | 2025-07-16 |
| K250684 | OPUSWAVE Dual Sensor Imaging System | Terumo Cardiovascular Systems Thi Plant | 2025-07-02 |
| K242924 | OPXION Optical Skin Viewer (OPXSV1-01F) | Opxion Technology, Inc. | 2025-06-23 |
| K242098 | Cornaris 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 |
| K243016 | Starlight Imaging Catheter | Spectrawave, Inc. | 2025-03-20 |
| K242239 | HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30 (Vis-Rx Micro-Imaging Catheter)) | Gentuity, LLC | 2024-08-16 |
| K240610 | deepLive | Damae Medical | 2024-07-09 |
| K232386 | ILUMIEN OPTIS System, OPTIS Integrated System, OPTIS Mobile System, with AptiVue Imaging Software version E.6 | ABBOTT MEDICAL | 2023-09-08 |
| K230691 | HyperVue Imaging System | Spectrawave, Inc. | 2023-06-07 |
| K221257 | SpectraWAVE Imaging System | Spectrawave, Inc. | 2023-02-28 |
| K210458 | OPTIS Mobile Next Imaging System, OPTIS Integrated Next Imaging System | ABBOTT MEDICAL | 2021-06-08 |
| K203578 | OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System | Perimeter Medical Imaging Ai, Inc. | 2021-02-25 |