510(k) K203578
- Device
- OTIS 2.1 Optical Coherence Tomography System, THiA Optical Coherence Tomography System
- Applicant
- Perimeter Medical Imaging AI, Inc.
- 510(k) number
- K203578
- Product code
- NQQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-02-25
- Date received
- 2020-12-07
- Regulation
- 892.1560
- Classification name
- System, Imaging, Optical Coherence Tomography (oct)
- Medical specialty
- Radiology
- Review panel
- General & Plastic Surgery
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Elizabeth Munro
- Address
- 359 Eastern Ave., Suite 110 Toronto CA M4M 1B7 M4M 1B7
FDA Registration Numbers#
- 3005228872
- 3011578544
- 3009600098
- 1221051
- 3027259266
- 2245304
- 3004091615
- 3013440400
- 3038165043
- 3010126772
- 3021630097
- 3004837686
- 3009882464
- 3012179728
- 3042929028
- 2024311
- 3013351723
- 1220477
- 2246552
- 2030624
- 2024168
- 3042970803
- 3013276158
- 3007603861
- 3017654247
- 3012198618
- 3043527620
Source Documents#
Other 510(k) Records For Product Code NQQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K253459 | OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System (1014933); Ultreon 3.0 Software Upgrade Kit (ULTR300001) | ABBOTT MEDICAL | 2026-04-24 |
| 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 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases