Rapid NCCT Stroke
510(k) K222884
Rapid NCCT Stroke is a medical device (FDA Class II; FDA product code QAS, Radiological Computer-Assisted Triage And Notification Software) made by iSchemaView, Inc., cleared under FDA 510(k) K222884 on 2 Mar 2023, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK222884 | Date2 Mar 2023 | StatusActive |
Official records
- FDA 510(k) database K222884
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- QAS
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2080
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K222884
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| Rapid 6.1.0 | 6.1.0 | B761R610 | — | On the market |
Similar devices
Other devices filed under FDA product code QAS (Radiological Computer-Assisted Triage And Notification Software).
- EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100) by Ever Fortune.Ai, Co., Ltd.
- Methinks NCCT Stroke by Methinks Software, S.L
- Annalise Enterprise CTB Triage Trauma by Annalise-Ai Pty, Ltd.
- Heuron ICH by Heuron Co., Ltd.
- HealthICH by Zebra Medical Vision, Ltd.
- qER by Qure.Ai Technologies
- Contact by Viz.Al, Inc.
- StrokeSENS LVO by Circle Neurovascular Imaging, Inc.
- DeepCT by Deep01 Limited
- InferRead CT Stroke.AI by Infervision Medical Technology Co., Ltd.