The following data is part of a premarket notification filed by Annalise-ai with the FDA for Annalise Enterprise Cxr Triage Pneumothorax.
| Device ID | K213941 |
| 510k Number | K213941 |
| Device Name: | Annalise Enterprise CXR Triage Pneumothorax |
| Classification | Radiological Computer-assisted Prioritization Software For Lesions |
| Applicant | Annalise-AI Level 21, 60 Margaret Street Sydney, AU 2000 |
| Contact | Eric Qin |
| Correspondent | Michele Houldsworth Annalise-AI Level 21, 60 Margaret Street Sydney, AU 2000 |
| Product Code | QFM |
| CFR Regulation Number | 892.2080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-16 |
| Decision Date | 2022-02-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| G140ANNALISEENTP20 | K213941 | 000 |
| G140ANNALISEENTP30 | K213941 | 000 |
| G140ANNALISEENTP40 | K213941 | 000 |
| G140ANNALISEENTP50 | K213941 | 000 |