FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
HealthJOINT
K Number: K202487
·
Decision Dec 4, 2020
Classifications
1
FEI Numbers
599
Registration Numbers
599
Same Product Code
2271
Applicant Total
9
Review Days
95
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Basic Information
- Device Name
- HealthJOINT
- K Number
- K202487
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.2050
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Zebra Medical Vision, Ltd.
- Date Received
- August 31, 2020
- Decision Date
- December 4, 2020
- Product Code
- LLZ
- 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 |
|---|---|---|---|
| LLZ | System, Image Processing, Radiological | 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 |
| 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 |
| K190362 | HealthPNX | May 6, 2019 | Substantially Equivalent |
| K172983 | HealthCCS | Jun 13, 2018 | Substantially Equivalent |