FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
HealthMammo
K Number: K200905
·
Decision Jul 16, 2020
Classifications
1
FEI Numbers
22
Registration Numbers
22
Same Product Code
39
Applicant Total
9
Review Days
101
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Basic Information
- Device Name
- HealthMammo
- K Number
- K200905
- 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
- April 6, 2020
- Decision Date
- July 16, 2020
- 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 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 |
| K192901 | HealthVCF | May 12, 2020 | Substantially Equivalent |
| K192320 | HealthCXR | Nov 26, 2019 | Substantially Equivalent |
| K190424 | HealthICH | Jun 13, 2019 | Substantially Equivalent |
| K190362 | HealthPNX | May 6, 2019 | Substantially Equivalent |
| K172983 | HealthCCS | Jun 13, 2018 | Substantially Equivalent |