Total clearances
20
2020-06-26 → 2026-07-13
Name variants in FDA filings: iSchemaview / Ischemaview / Ischemaview, Inc.
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| QAS |
Radiological Computer-Assisted Triage And Notification Software |
Class II |
Radiology |
9 |
2026-07-13 |
| QIH |
Automated Radiological Image Processing Software |
Class II |
Radiology |
5 |
2025-09-23 |
| LLZ |
System, Image Processing, Radiological |
Class II |
Radiology |
3 |
2025-08-26 |
| POK |
— |
— |
— |
2 |
2024-01-19 |
| QFM |
Radiological Computer-Assisted Prioritization Software For Lesions |
Class II |
Radiology |
1 |
2023-07-27 |
Filings
All 510(k) clearances (20)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2026-07-13 |
K261085 |
Rapid Vessel Occlusion (Rapid VO) |
QAS |
Class II |
Radiology |
| 2025-09-23 |
K251987 |
Rapid Aortic Measurements |
QIH |
Class II |
Radiology |
| 2025-09-04 |
K251533 |
Rapid Obstructive Hydrocephalus, Rapid OH |
QAS |
Class II |
Radiology |
| 2025-08-26 |
K252526 |
Rapid DeltaFuse |
LLZ |
Class II |
Radiology |
| 2025-07-16 |
K251151 |
Rapid CTA 360 |
QAS |
Class II |
Radiology |
| 2025-05-28 |
K243378 |
Rapid MLS |
QIH |
Class II |
Radiology |
| 2025-01-22 |
K243350 |
Rapid Neuro3D |
QIH |
Class II |
Radiology |
| 2024-04-22 |
K233582 |
Rapid |
LLZ |
Class II |
Radiology |
| 2024-01-19 |
K232156 |
Rapid ASPECTS (v3) |
POK |
— |
— |
| 2024-01-16 |
K233512 |
Rapid (6.0) |
QIH |
Class II |
Radiology |
| 2023-10-25 |
K232436 |
Rapid SDH |
QAS |
Class II |
Radiology |
| 2023-07-27 |
K230074 |
Rapid Aneurysm Triage and Notification |
QFM |
Class II |
Radiology |
| 2023-03-02 |
K222884 |
Rapid NCCT Stroke |
QAS |
Class II |
Radiology |
| 2023-02-01 |
K223396 |
Rapid RV/LV |
QIH |
Class II |
Radiology |
| 2022-09-12 |
K221456 |
Rapid ICH |
QAS |
Class II |
Radiology |
| 2022-05-31 |
K221248 |
Rapid LVO |
QAS |
Class II |
Radiology |
| 2022-05-17 |
K220499 |
Rapid PE Triage and Notification (PETN) |
QAS |
Class II |
Radiology |
| 2022-02-08 |
K213165 |
Rapid |
LLZ |
Class II |
Radiology |
| 2020-07-09 |
K200941 |
Rapid LVO |
QAS |
Class II |
Radiology |
| 2020-06-26 |
K200760 |
Rapid ASPECTS |
POK |
— |
— |