FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
X1-FFR
K Number: K251355
·
Decision Oct 17, 2025
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
6
Applicant Total
6
Review Days
170
Basic Information
- Device Name
- X1-FFR
- K Number
- K251355
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1600
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spectrawave, Inc.
- Date Received
- April 30, 2025
- Decision Date
- October 17, 2025
- Product Code
- QHA
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- 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 |
|---|---|---|---|
| QHA | X-Ray Angiographic Imaging Based Coronary Vascular Simulation Software Device | FDA class 2 | Radiology |
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Other Clearances by Spectrawave, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K253101 | HyperVue Imaging System - Integrated | Dec 15, 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 |