15 devices · 3 companies · 2018 to 2025
iSchemaView, Inc.: AI-enabled devices on FDA's list
15 devices from iSchemaView, Inc., 2018 to 2025, from 3 companies across 5 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (13 of 15 here), the regulation, and MAUDE report counts by product code.
Retrieved from FDA public records.
Product codes from iSchemaView, Inc.
- QAS · Radiological Computer-Assisted Triage And Notification Software7
- QIH · Automated Radiological Image Processing Software4
- POK · Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer2
- QFM · Radiological Computer-Assisted Prioritization Software For Lesions1
- LLZ · System, Image Processing, Radiological1
Every device, newest decision first
| Decision | Device | Panel | Product code | FDA |
|---|---|---|---|---|
| Rapid Aortic MeasurementsK251987 · 510(k) | Radiology | QIH | database entry | |
| Rapid Obstructive Hydrocephalus, Rapid OHK251533 · 510(k) | Radiology | QAS | database entry | |
| Rapid MLSK243378 · 510(k) | Radiology | QIH | database entry | |
| Rapid Neuro3DK243350 · 510(k) | Radiology | QIH | database entry | |
| Rapid ASPECTSK232156 · 510(k) | Radiology | POK | database entry | |
| RapidK233512 · 510(k) | Radiology | QIH | database entry | |
| Rapid SDHK232436 · 510(k) | Radiology | QAS | database entry | |
| Rapid Aneurysm Triage and NotificationK230074 · 510(k) | Radiology | QFM | database entry | |
| Rapid NCCT StrokeK222884 · 510(k) | Radiology | QAS | database entry | |
| Rapid ICHK221456 · 510(k) | Radiology | QAS | database entry | |
| Rapid LVOK221248 · 510(k) | Radiology | QAS | database entry | |
| Rapid PE Triage and NotificationK220499 · 510(k) | Radiology | QAS | database entry | |
| Rapid LVOK200941 · 510(k) | Radiology | QAS | database entry | |
| Rapid ASPECTSK200760 · 510(k) | Radiology | POK | database entry | |
| iSchemaView RAPIDK182130 · 510(k) | Radiology | LLZ | database entry |
Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.