HyperVue Imaging System - Integrated
FDA 510(k) K253101 · Spectrawave, Inc.
510(k) numberK253101
Submission
- Device name
- HyperVue Imaging System - Integrated
- Applicant
- Spectrawave, Inc.
Bedford, MA, US - Received
- September 24, 2025
- Decision date
- December 15, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- NQQ – System, Imaging, Optical Coherence Tomography (Oct)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 892.1560
- Specialty
- Radiology
This device uses back-reflected light to create two-dimensional images versus back-reflected sound waves as are used in ultrasound imaging.
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|---|---|---|---|
| K253459 | OPTIS Mobile Next Imaging System (1014932); OPTIS Integrated Next Imaging System…NQQ · Traditional | Abbott Medical | 04/24/2026SE |
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| K252851 | deepLive (OSP12 + DMS)NQQ · Special | Damae Medical | 10/07/2025SE |
| K251198 | HyperVue SoftwareNQQ · Traditional | Spectrawave, Inc. | 07/16/2025SE |
| K250684 | OPUSWAVE Dual Sensor Imaging SystemNQQ · Traditional | Terumo Cardiovascular Systems Thi Plant | 07/02/2025SE |
| K242924 | OPXION Optical Skin Viewer (OPXSV1-01F)NQQ · Traditional | Opxion Technology, Inc. | 06/23/2025SE |
| K242098 | Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System…NQQ · Traditional | Shenzhen Vivolight Medical Device & Technology… | 04/11/2025SE |
| K243016 | Starlight Imaging CatheterNQQ · Special | Spectrawave, Inc. | 03/20/2025SE |
| K242239 | HF-OCT Imaging System with Vis-RX Micro-Imaging Catheter (G10 (HF-OCT Console), G30…NQQ · Special | Gentuity, LLC | 08/16/2024SE |
| K240610 | deepLiveNQQ · Traditional | Damae Medical | 07/09/2024SE |
More from Damae Medical
| 510(k) | Device | Decision |
|---|---|---|
| K251355 | X1-FFRQHA · Traditional | 10/17/2025SE |
| K251198 | HyperVue SoftwareNQQ · Traditional | 07/16/2025SE |
| K243016 | Starlight Imaging CatheterNQQ · Special | 03/20/2025SE |
| K230691 | HyperVue Imaging SystemNQQ · Traditional | 06/07/2023SE |
| K221257 | SpectraWAVE Imaging SystemNQQ · Traditional | 02/28/2023SE |
Questions and answers
When was HyperVue Imaging System - Integrated cleared by the FDA?
HyperVue Imaging System - Integrated (K253101) received a 510(k) decision of Substantially Equivalent on December 15, 2025, 82 days after the submission was received.
What is the product code of K253101?
The FDA product code is NQQ – System, Imaging, Optical Coherence Tomography (Oct), a Class II (moderate risk) device regulated under 21 CFR 892.1560.