GenIQ
System, Image Processing, Radiological
GE MEDICAL SYSTEMS, LLC.
The following data is part of a premarket notification filed by Ge Medical Systems, Llc. with the FDA for Geniq.
Pre-market Notification Details
| Device ID | K143368 |
| 510k Number | K143368 |
| Device Name: | GenIQ |
| Classification | System, Image Processing, Radiological |
| Applicant | GE MEDICAL SYSTEMS, LLC. 3200 N. GRANDVIEW BLVD Waukesha, WI 53188 |
| Contact | Jenny Wong |
| Correspondent | Jenny Wong GE MEDICAL SYSTEMS, LLC. 3200 N. GRANDVIEW BLVD Waukesha, WI 53188 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-25 |
| Decision Date | 2015-07-29 |
| Summary: | summary |
Trademark Results [GenIQ]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 GENIQ 88606644 not registered Live/Pending |
MERKIN, RICHARD 2019-09-06 |
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