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United States·US-MF-000040716
Last updated September 17, 2026
Information
- Country
- United States
- Address
- 1120 Washington Ave, Golden, United States
- Website
- ischemaview.com
- —
- —
- [email protected]
- Phone
- 3037043374
- PRRC Contact
- Jim Rosa
- EUDAMED SRN
- US-MF-000040716
- FDA FEI Number
- 3014269683
- DUNS Number
- 079477740
Catalogue (42)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Rapid | 5.7.1 | FDA UDI | Class II | Active |
| Rapid | 5.0 | FDA UDI | Class II | Active |
| Rapid | 4.8.3 | FDA UDI | Class II | Active |
| Rapid | 5.9 | FDA UDI | Class II | Active |
| Rapid | 5.7 | FDA UDI | Class II | Active |
| Rapid | 5.7.2 | FDA UDI | Class II | Active |
| Rapid | 5.1.2 | FDA UDI | Class II | Active |
| Rapid | 6.1.0 | FDA UDI | Class II | Active |
| Rapid | 5.0.1 | FDA UDI | Class II | Active |
| Rapid | 4.9.1 | FDA UDI | Class II | Active |
| Rapid | 5.0.2.1 | FDA UDI | Class II | Active |
| Rapid | 5.1 | FDA UDI | Class II | Active |
| Rapid | 5.5.1 | FDA UDI | Class II | Active |
| Rapid | 5.2.0 | FDA UDI | Class II | Active |
| Rapid | 5.1.1 | FDA UDI | Class II | Active |
| Rapid | 5.0.3 | FDA UDI | Class II | Active |
| Rapid | 6.x | FDA UDI | Class II | Active |
| Rapid | 5.101 | FDA UDI | Class II | Active |
| Rapid | 5.102 | FDA UDI | Class II | Active |
| Rapid | 5.0.2 | FDA UDI | Class II | Active |
| Rapid | 5.2.2 | FDA UDI | Class II | Active |
| Rapid | 5.2.2 | FDA UDI | Class II | Active |
| Rapid ICH | K221456 | FDA 510(k) | Class II | Active |
| Rapid Obstructive Hydrocephalus, Rapid OH | K251533 | FDA 510(k) | Class II | Active |
| Rapid ASPECTS | K200760 | FDA 510(k) | Class II | Active |
| Rapid Neuro3D | K243350 | FDA 510(k) | Class II | Active |
| Rapid ASPECTS (v3) | K232156 | FDA 510(k) | Class II | Active |
| Rapid Aneurysm Triage and Notification | K230074 | FDA 510(k) | Class II | Active |
| Rapid NCCT Stroke | K222884 | FDA 510(k) | Class II | Active |
| Rapid PE Triage and Notification (PETN) | K220499 | FDA 510(k) | Class II | Active |
| Rapid DeltaFuse | K252526 | FDA 510(k) | Class II | Active |
| Rapid MLS | K243378 | FDA 510(k) | Class II | Active |
| Rapid Aortic Measurements | K251987 | FDA 510(k) | Class II | Active |
| Rapid RV/LV | K223396 | FDA 510(k) | Class II | Active |
| Rapid SDH | K232436 | FDA 510(k) | Class II | Active |
| Rapid (6.0) | K233512 | FDA 510(k) | Class II | Active |
| Rapid CTA 360 | K251151 | FDA 510(k) | Class II | Active |
| Rapid LVO | K200941 | FDA 510(k) | Class II | Active |
| Rapid LVO | K221248 | FDA 510(k) | Class II | Active |
| Advanced Imaging Toolkit | Advanced Imaging Toolkit v1.x | EUDAMED | Class IIb | Active |
| RAPID Software | N/A | EUDAMED | Class IIa | Active |
| Lumina 3D | Lumina 3D v1.x | EUDAMED | Class IIb | Active |
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