FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇷 France
CardIQ Suite
K Number: K243672
·
Decision Jun 18, 2025
Classifications
1
FEI Numbers
164
Registration Numbers
164
Same Product Code
795
Applicant Total
23
Review Days
203
Basic Information
- Device Name
- CardIQ Suite
- K Number
- K243672
- 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 27, 2024
- Decision Date
- June 18, 2025
- 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 |
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Other Clearances by GE Medical Systems SCS
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K223152 | Vision 2, EVARVision, TrackVision 2, HeartVision 2 | Nov 22, 2022 | Substantially Equivalent |
| K222895 | DynamicIQ | Nov 22, 2022 | Substantially Equivalent |
| K211180 | Liver Suite | May 2, 2022 | Substantially Equivalent |