Identifiers
- 510(k) Number
- K143368 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)
GenIQ is a medical device manufactured by GE Medical Systems, LLC. It is identified under FDA 510(k) clearance K143368.
This device is subject to FDA 510(k) premarket notification requirements. It is categorized under the radiology advisory committee and product code LLZ.
Frequently asked questions
What is the regulatory status of the GenIQ device?
The GenIQ device is subject to FDA 510(k) premarket notification requirements. It received clearance under K143368 on July 29, 2015, after being determined to be substantially equivalent to predicate devices.
Which medical specialty is this device associated with?
GenIQ is categorized under the radiology advisory committee, which oversees medical devices used for diagnostic imaging and related radiological procedures.
Who is the manufacturer of the GenIQ device?
GenIQ is manufactured by GE Medical Systems, LLC, located in Waukesha, Wisconsin. The company submitted the device for review under the traditional 510(k) process.
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: PDF GenIQ, English | GE HealthCare (United States), ge medical systems | General Electric, K143368 FDA 510 (k) - GenIQ | Ge Medical Systems, LLC, Geniq 510 (k) FDA Premarket Notification K143368 GE MEDICAL SYSTEMS, LLC.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K143368 | Class II | Active |
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Manufacturer
- Manufacturer
- Ge Medical Systems, Inc.
- FDA Applicant
- Ge Medical Systems, LLC
Sources (1)
- FDA 510(k) K143368 24 fields · synced Sep 22, 2026