FDA 510(k)
FDA class 2
Substantially Equivalent
🇦🇺 Australia
Annalise Enterprise CXR Triage Trauma
K Number: K222268
·
Decision Mar 28, 2023
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
39
Applicant Total
6
Review Days
243
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Basic Information
- Device Name
- Annalise Enterprise CXR Triage Trauma
- K Number
- K222268
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2080
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Annalise-Ai Pty , Ltd.
- Date Received
- July 28, 2022
- Decision Date
- March 28, 2023
- Product Code
- QFM
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QFM | Radiological Computer-Assisted Prioritization Software For Lesions | FDA class 2 | Radiology |
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Other Clearances by Annalise-Ai Pty , Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K231767 | Annalise Enterprise CTB Triage Trauma | Sep 22, 2023 | Substantially Equivalent |
| K231384 | Annalise Enterprise CTB Triage Trauma | Sep 22, 2023 | Substantially Equivalent |
| K231094 | Annalise Enterprise CTB Triage-OH | Aug 15, 2023 | Substantially Equivalent |
| K223240 | Annalise Enterprise CTB Triage Trauma | Apr 3, 2023 | Substantially Equivalent |
| K222179 | Annalise Enterprise CXR Triage Trauma | Mar 28, 2023 | Substantially Equivalent |