Company ยท US
Ischemaview, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2013 to 2026. Name variants (Inc, Corp, punctuation) are merged.
26510(k) clearances (3 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| QAS | Radiological Computer-Assisted Triage And Notification Software | 11 |
| LLZ | System, Image Processing, Radiological | 6 |
| QIH | Automated Radiological Image Processing Software | 6 |
| POK | Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer | 2 |
| QFM | Radiological Computer-Assisted Prioritization Software For Lesions | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 9, 2026 | K262301 | Rapid ICH (v4.0) Ischemaview, Inc. | QAS |
| Sep 21, 2026 | K261368 | Rapid Platform (R6.7) Ischemaview, Inc. | QIH |
| Jul 13, 2026 | K261085 | Rapid Vessel Occlusion (Rapid VO) iSchemaview | QAS |
| Sep 23, 2025 | K251987 | Rapid Aortic Measurements Ischemaview, Inc. | QIH |
| Sep 4, 2025 | K251533 | Rapid Obstructive Hydrocephalus, Rapid OH Ischemaview, Inc. | QAS |
| Aug 26, 2025 | K252526 | Rapid DeltaFuse Ischemaview, Inc. | LLZ |
| Jul 16, 2025 | K251151 | Rapid CTA 360 Ischemaview | QAS |
| May 28, 2025 | K243378 | Rapid MLS Ischemaview, Inc. | QIH |
| Jan 22, 2025 | K243350 | Rapid Neuro3D Ischemaview, Inc. | QIH |
| Apr 22, 2024 | K233582 | Rapid Ischemaview, Inc. | LLZ |
| Jan 19, 2024 | K232156 | Rapid ASPECTS (v3) Ischemaview, Inc. | POK |
| Jan 16, 2024 | K233512 | Rapid (6.0) Ischemaview, Inc. | QIH |
| Oct 25, 2023 | K232436 | Rapid SDH Ischemaview, Inc. | QAS |
| Jul 27, 2023 | K230074 | Rapid Aneurysm Triage and Notification Ischemaview, Inc. | QFM |
| Mar 2, 2023 | K222884 | Rapid NCCT Stroke Ischemaview, Inc. | QAS |
| Feb 1, 2023 | K223396 | Rapid RV/LV Ischemaview, Inc. | QIH |
| Sep 12, 2022 | K221456 | Rapid ICH Ischemaview, Inc. | QAS |
| May 31, 2022 | K221248 | Rapid LVO Ischemaview, Inc. | QAS |
| May 17, 2022 | K220499 | Rapid PE Triage and Notification (PETN) Ischemaview, Inc. | QAS |
| Feb 8, 2022 | K213165 | Rapid Ischemaview, Inc. | LLZ |
| Jul 9, 2020 | K200941 | Rapid LVO Ischemaview, Inc. | QAS |
| Jun 26, 2020 | K200760 | Rapid ASPECTS Ischemaview, Inc. | POK |
| Mar 31, 2020 | K193087 | Rapid ICH Ischemaview Incorporated | QAS |
| Dec 27, 2018 | K182130 | iSchemaView RAPID Ischemaview, Inc. | LLZ |
| Apr 19, 2018 | K172477 | iSchemaView RAPID Ischemaview, Inc. | LLZ |
| Oct 4, 2013 | K121447 | ISCHEMA VIEW RAPID Ischemaview, Inc. | LLZ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||