FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
cmTriage
K Number: K183285
·
Decision Mar 8, 2019
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
37
Applicant Total
1
Review Days
102
Basic Information
- Device Name
- cmTriage
- K Number
- K183285
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2080
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- CureMetrix, Inc
- Date Received
- November 26, 2018
- Decision Date
- March 8, 2019
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (QFM), ordered by most recent decision date.
Annalise Enterprise
FDA 510(k)
FDA Class 2
·Radiology
Rayvolve PTX-PE
FDA 510(k)
FDA Class 2
·Radiology
BriefCase-Triage
FDA 510(k)
FDA Class 2
·Radiology
VUNO Med-Chest X-ray Triage/VUNO Med-CXR Link Triage
FDA 510(k)
FDA Class 2
·Radiology
CINA-VCF
FDA 510(k)
FDA Class 2
·Radiology
VinDr-Mammo
FDA 510(k)
FDA Class 2
·Radiology