GenIQ
510(k) K143368
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK143368 | Date29 Jul 2015 | StatusActive |
Official records
- FDA 510(k) database K143368
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- LLZ
- FDA applicant
- Ge Medical Systems, LLC
- Device class
- Class II
- Regulation
- 21 CFR Part 892.2050
- Advisory committee
- Radiology
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 22 Sep 2026
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.
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