FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
CardIQ Suite
K Number: K213725
·
Decision Mar 11, 2022
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
818
Applicant Total
37
Review Days
105
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
- CardIQ Suite
- K Number
- K213725
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1750
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- GE Medical Systems SCS
- Date Received
- November 26, 2021
- Decision Date
- March 11, 2022
- 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 GE Medical Systems SCS
| K Number | Device Name | ||
|---|---|---|---|
| K260087 | Senographe Pristina; SenoBright HD; Pristina Serena; Pristina Serena Bright | Mar 24, 2026 | Substantially Equivalent |
| K251199 | Allia Moveo | Dec 9, 2025 | Substantially Equivalent |
| K243672 | CardIQ Suite | Jun 18, 2025 | Substantially Equivalent |
| K243651 | VersaViewer | Apr 21, 2025 | Substantially Equivalent |
| K243446 | 3DXR | Feb 25, 2025 | Substantially Equivalent |
| K233731 | CardIQ Suite | Aug 1, 2024 | Substantially Equivalent |
| K233714 | BreView | Jan 25, 2024 | Substantially Equivalent |
| K232344 | Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OR | Oct 11, 2023 | Substantially Equivalent |
| K223424 | Spine Auto Views | Jul 13, 2023 | Substantially Equivalent |
| K223490 | FlightPlan for Embolization | Mar 21, 2023 | Substantially Equivalent |