FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HyperVue Imaging System - Integrated
K Number: K253101
·
Decision Dec 15, 2025
Classifications
1
FEI Numbers
27
Registration Numbers
27
Same Product Code
45
Applicant Total
6
Review Days
82
Basic Information
- Device Name
- HyperVue Imaging System - Integrated
- K Number
- K253101
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1560
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spectrawave, Inc.
- Date Received
- September 24, 2025
- Decision Date
- December 15, 2025
- Product Code
- NQQ
- Advisory Committee
- Radiology
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| NQQ | System, Imaging, Optical Coherence Tomography (Oct) | FDA class 2 | Radiology |
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Other Clearances by Spectrawave, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K251355 | X1-FFR | Oct 17, 2025 | Substantially Equivalent |
| K251198 | HyperVue Software | Jul 16, 2025 | Substantially Equivalent |
| K243016 | Starlight Imaging Catheter | Mar 20, 2025 | Substantially Equivalent |
| K230691 | HyperVue Imaging System | Jun 7, 2023 | Substantially Equivalent |
| K221257 | SpectraWAVE Imaging System | Feb 28, 2023 | Substantially Equivalent |