VesselIQ Xpress
FDA 510(k) K200626 · GE Medical Systems SCS
510(k) numberK200626
Submission
- Device name
- VesselIQ Xpress
- Applicant
- GE Medical Systems SCS
Buc, FR - Received
- March 10, 2020
- Decision date
- February 16, 2021
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K233731 | CardIQ SuiteJAK · Traditional | 08/01/2024SE |
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| K232344 | Allia IGS 3, Allia IGS 5, Allia IGS 7, Allia IGS 7 OROWB · Special | 10/11/2023SE |
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Questions and answers
When was VesselIQ Xpress cleared by the FDA?
VesselIQ Xpress (K200626) received a 510(k) decision of Substantially Equivalent on February 16, 2021, 343 days after the submission was received.
What is the product code of K200626?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.