Identifiers
- 510(k) Number
- K121762 FDA 510(k)
- FDA Product Code
- LLZ FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2050 FDA 510(k)
- Regulation Number
- 892.2050 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Cardiac Vx is a medical imaging system. It is classified as a Radiology device. The device has a product code of LLZ.
The Cardiac Vx is supplied by GE Medical Systems, LLC and has received FDA 510(k) clearance, with the reference number K121762. It was cleared on January 18, 2013. The device is used in the field of Radiology.
Frequently asked questions
What is the Cardiac Vx used for?
The Cardiac Vx is used in the field of Radiology as a medical imaging system.
Is the Cardiac Vx cleared by the FDA?
Yes, the Cardiac Vx has received FDA 510(k) clearance with the reference number K121762, indicating it is substantially equivalent to a predicate device.
Who supplies the Cardiac Vx?
The Cardiac Vx is supplied by GE Medical Systems, LLC, with a contact person of Michelle Huettner.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: GE Cardiac VX - allmed.wiki, CARDIAC VX (K121762) - FDA 510 (k), PDF K121762 - Cardiac Vx, CARDIAC VX (K121762) — FDA 510(k) | Innolitics
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K121762 | Class II | Active |
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Manufacturer
- Manufacturer
- GE Medical Systems, LLC
Sources (1)
- FDA 510(k) K121762 24 fields · synced Sep 22, 2026