X1-FFR
FDA 510(k) clearance K251355 · decided 2025-10-17
Clearance details
- K-number
- K251355
- Device name
- X1-FFR
- Applicant
- Spectrawave, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2025-04-30
- Decision date
- 2025-10-17
- Days to decision
- 170 days
- Clearance type
- Traditional
- Product code
- QHA
- Device class
- 2
- Regulation number
- 892.1600
- Medical specialty
- Radiology
- Advisory committee
- Radiology
- Location
- Bedford, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| QFR (3.0) (K243769) | Qfr Solutions BV | 2025-04-04 |
| CAAS Workstation (K232147) | Pie Medical Imaging BV | 2024-04-09 |
| AccuFFRangio Plus (K230303) | ArteryFlow Technology Co., Ltd. | 2023-03-02 |
| AccuICAS (K221711) | ArteryFlow Technology Co., Ltd. | 2023-02-28 |
| AccuFFRangio (K210093) | ArteryFlow Technology Co., Ltd. | 2021-09-10 |
| Qangio XA 3D (K182611) | Medis Medical Imaging Systems BV | 2019-05-30 |
Recalls involving this device
No recalls on record reference this clearance.