FDA Product Code
FDA Product Code QHA — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1600
510(k) Clearances — 7 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K251355 | X1-FFR | Spectrawave, Inc. | 2025-10-17 | Traditional | PDF ↗ |
| K243769 | QFR (3.0) | Qfr Solutions BV | 2025-04-04 | Traditional | PDF ↗ |
| K232147 | CAAS Workstation | Pie Medical Imaging BV | 2024-04-09 | Traditional | PDF ↗ |
| K230303 | AccuFFRangio Plus | ArteryFlow Technology Co., Ltd. | 2023-03-02 | Special | PDF ↗ |
| K221711 | AccuICAS | ArteryFlow Technology Co., Ltd. | 2023-02-28 | Traditional | PDF ↗ |
| K210093 | AccuFFRangio | ArteryFlow Technology Co., Ltd. | 2021-09-10 | Traditional | PDF ↗ |
| K182611 | Qangio XA 3D | Medis Medical Imaging Systems BV | 2019-05-30 | Traditional | PDF ↗ |
Product code QHA · Class II · Radiology. Data: openFDA.