FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
HealthCCSng
K Number: K210085
·
Decision Sep 15, 2021
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
818
Applicant Total
9
Review Days
245
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
- HealthCCSng
- K Number
- K210085
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Zebra Medical Vision, Ltd.
- Date Received
- January 13, 2021
- Decision Date
- September 15, 2021
- Product Code
- JAK
- 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 |
|---|---|---|---|
| JAK | System, X-Ray, Tomography, Computed | FDA class 2 | Radiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JAK), ordered by most recent decision date.
Respiratory Gating for Scanners (2.1)
FDA 510(k)
FDA Class 2
·Radiology
Aquilion ONE (TSX-308A/TSX-306A) V2.0
FDA 510(k)
FDA Class 2
·Radiology
Spectral CT Verida Family
FDA 510(k)
FDA Class 2
·Radiology
True Definition DL
FDA 510(k)
FDA Class 2
·Radiology
CT Rembra RT; CT Areta RT; CT Rembra
FDA 510(k)
FDA Class 2
·Radiology
SOMATOM X.cite; SOMATOM X.ceed
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 |
| 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 |
| K190362 | HealthPNX | May 6, 2019 | Substantially Equivalent |
| K172983 | HealthCCS | Jun 13, 2018 | Substantially Equivalent |