FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
HealthPNX
K Number: K190362
·
Decision May 6, 2019
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
39
Applicant Total
9
Review Days
80
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- HealthPNX
- K Number
- K190362
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2080
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Zebra Medical Vision, Ltd.
- Date Received
- February 15, 2019
- Decision Date
- May 6, 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.
MammoSightAI
FDA 510(k)
FDA Class 2
·Radiology
CogNet AI-MT+
FDA 510(k)
FDA Class 2
·Radiology
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
Other Clearances by Zebra Medical Vision, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K211803 | HealthPPT | Dec 15, 2021 | Substantially Equivalent |
| K210085 | HealthCCSng | Sep 15, 2021 | Substantially Equivalent |
| K202487 | HealthJOINT | Dec 4, 2020 | Substantially Equivalent |
| K200905 | HealthMammo | Jul 16, 2020 | Substantially Equivalent |
| K192901 | HealthVCF | May 12, 2020 | Substantially Equivalent |
| K192320 | HealthCXR | Nov 26, 2019 | Substantially Equivalent |
| K190424 | HealthICH | Jun 13, 2019 | Substantially Equivalent |
| K172983 | HealthCCS | Jun 13, 2018 | Substantially Equivalent |