Annalise Enterprise CXR Triage Pneumothorax — Annalise-Ai (510(k) K213941)
Annalise Enterprise CXR Triage Pneumothorax — Annalise-Ai (510(k) K213941) is one of 9,000 device clearances in the DeviceClear dataset. Key details — Device name: Annalise Enterprise CXR Triage Pneumothorax; Applicant: Annalise-Ai; Clearance track: 510(k).
| Device name | Annalise Enterprise CXR Triage Pneumothorax |
|---|---|
| Applicant | Annalise-Ai |
| Clearance track | 510(k) |
| Submission number | K213941 |
| Decision | Substantially Equivalent |
| Decision date | 2022-02-24 |
| Date received | 2021-12-16 |
| Product code | QFM |
| Device class | 2 |
| Medical specialty | Radiology |
| Applicant location | AU |
| Source | openFDA device |
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$1999/mo
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