SpectraWAVE Imaging System
FDA 510(k) K221257 · Spectrawave, Inc.
510(k) numberK221257
Submission
- Device name
- SpectraWAVE Imaging System
- Applicant
- Spectrawave, Inc.
Bedford, MA, US - Received
- May 2, 2022
- Decision date
- February 28, 2023
- 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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More from Gentuity, LLC
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| K253101 | HyperVue Imaging System - IntegratedNQQ · Traditional | 12/15/2025SE |
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| K251198 | HyperVue SoftwareNQQ · Traditional | 07/16/2025SE |
| K243016 | Starlight Imaging CatheterNQQ · Special | 03/20/2025SE |
| K230691 | HyperVue Imaging SystemNQQ · Traditional | 06/07/2023SE |
Questions and answers
When was SpectraWAVE Imaging System cleared by the FDA?
SpectraWAVE Imaging System (K221257) received a 510(k) decision of Substantially Equivalent on February 28, 2023, 302 days after the submission was received.
What is the product code of K221257?
The FDA product code is NQQ – System, Imaging, Optical Coherence Tomography (Oct), a Class II (moderate risk) device regulated under 21 CFR 892.1560.