Mac-Lab/Cardiolab /combolab/Specialslab System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K061741 FDA 510(k)
- FDA Product Code
- DQK FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1425 FDA 510(k)
- Regulation Number
- 870.1425 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The MAC-LAB/CARDIOLAB/COMBOLAB/SPECIALSLAB SYSTEM is a cardiovascular device system intended for use in catheterization laboratories, electrophysiological laboratories, and related specialty laboratories under the direct supervision of a licensed healthcare practitioner. It is designed to support invasive cardiology procedures and related diagnostic and interventional functions.
The system is supplied as a reusable platform for clinical use in specialized laboratory settings. It has received FDA 510(k) clearance (K061741) under product code DQK, with a traditional clearance pathway and a decision of substantially equivalent. The device is manufactured by GE Healthcare and is not indicated as single-use or sterile; its use, storage, and handling are governed by the manufacturer's instructions for use in the specified clinical environments.
Frequently asked questions
What is the MAC-LAB/CARDIOLAB/COMBOLAB/SPECIALSLAB SYSTEM used for?
The system is intended for use in catheterization laboratories, electrophysiological laboratories, and related specialty laboratories to support invasive cardiology procedures and related diagnostic and interventional functions under the direct supervision of a licensed healthcare practitioner.
Is the MAC-LAB/CARDIOLAB/COMBOLAB/SPECIALSLAB SYSTEM supplied as sterile or single-use?
The device is not indicated as sterile or single-use; it is supplied as a reusable platform for clinical use in specialized laboratory settings, with use, storage, and handling governed by the manufacturer's instructions for use.
What regulatory clearance does the MAC-LAB/CARDIOLAB/COMBOLAB/SPECIALSLAB SYSTEM have?
The system has received FDA 510(k) clearance (K061741) under product code DQK, with a traditional clearance pathway and a decision of substantially equivalent, as stated in the authorization data.
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: Mac-lab/Cardiolab /Combolab/Specialslab System, Invasive Cardiology | GE HealthCare (United States), ComboLab | GE HealthCare (United States), GE Mac-Lab, CardioLab, Centricity Cardiology INW User manual
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K061741 | Class II | Active |
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Manufacturer
- Manufacturer
- GE Healthcare
Sources (1)
- FDA 510(k) K061741 24 fields · synced Sep 26, 2026