LOGIQ S8
K-Number: K170445 · 2017-04-11
ApplicantGE Healthcare
Decision Date2017-04-11
Product CodeIYN
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
LOGIQ S8 is a medical device manufactured by GE Healthcare. It received FDA 510(k) clearance on 2017-04-11 under approval number K170445. The device is classified under product code IYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the LOGIQ S8?
LOGIQ S8 is a medical device that received FDA 510(k) clearance on 2017-04-11. It is manufactured by GE Healthcare. The 510(k) number is K170445.
When was LOGIQ S8 approved by the FDA?
LOGIQ S8 received FDA 510(k) clearance on 2017-04-11, under approval number K170445.
What company makes LOGIQ S8?
LOGIQ S8 is manufactured by GE Healthcare.
What is the FDA product code for LOGIQ S8?
The FDA product code for LOGIQ S8 is IYN.
Related Clinical Trials
NCT06702917
GSI Cardiac on Revolution Apex - US
RECRUITING
NCT07263815
EQUIP - Evaluation of Quality of Imaging on a Next-generation Total Body Pet Scan in Comparison to Conventional PET
ACTIVE_NOT_RECRUITING
NCT07496918
Brain Effects of Gamma Frequency Sensory Stimulation (40Hz Light, Sound and Other Devices)
RECRUITING
Other Devices by GE Healthcare
Related Devices (Code: IYN)
K162845DC-40/DC-35/DC-45/DC-40S/DC-40 Pro Diagnostic Ultrasound SystemShenzhen Mindray Bio-Medical Electronics Co., Ltd.
K162902ARIETTA Prologue Diagnostic Ultrasound system and TransducersHitachi , Ltd.
K163138Clarius Ultrasound SystemClarius Mobile Health Corp.
K163077LOGIQ E9, LOGIQ E9 XDClear 2.0GE Medical Systems Ultrasound and Primary Care Diagnostics
K162583ALOKA LISENDO 880Hitachi , Ltd.
K163020Xperius Ultrasound SystemPhilips Health Care
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.