FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
HealthICH
K Number: K190424
·
Decision Jun 13, 2019
Classifications
1
FEI Numbers
19
Registration Numbers
19
Same Product Code
85
Applicant Total
9
Review Days
111
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Basic Information
- Device Name
- HealthICH
- K Number
- K190424
- 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 22, 2019
- Decision Date
- June 13, 2019
- Product Code
- QAS
- 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 |
|---|---|---|---|
| QAS | Radiological Computer-Assisted Triage And Notification Software | FDA class 2 | Radiology |
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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 |
| K190362 | HealthPNX | May 6, 2019 | Substantially Equivalent |
| K172983 | HealthCCS | Jun 13, 2018 | Substantially Equivalent |