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FDA 510(k)

Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish

K-Number: K180188 · 2018-06-07

ApplicantGenea Biomedx Pty, Ltd.
Decision Date2018-06-07
Product CodeMQG
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish is a medical device manufactured by Genea Biomedx Pty, Ltd.. It received FDA 510(k) clearance on 2018-06-07 under approval number K180188. The device is classified under product code MQG. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish?

Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish is a medical device that received FDA 510(k) clearance on 2018-06-07. It is manufactured by Genea Biomedx Pty, Ltd.. The 510(k) number is K180188.

When was Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish approved by the FDA?

Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish received FDA 510(k) clearance on 2018-06-07, under approval number K180188.

What company makes Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish?

Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish is manufactured by Genea Biomedx Pty, Ltd..

What is the FDA product code for Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish?

The FDA product code for Geri Embryo Incubator with Geri Connect and Geri Assess Software, and Geri Dish is MQG.

Related Clinical Trials

NCT07464275 Performance Assessment of the MAGENTA Blast Algorithm for Embryo Prediction COMPLETED NCT05236010 Control Network Neuromodulation to Enhance Cognitive Training in Complex Traumatic Brain Injury RECRUITING NCT01621594 Evaluating New Radiation Techniques for Cardiovascular Imaging RECRUITING NCT03768648 Cognition and MRI Markers in MS Patients With Aubagio® Treatment COMPLETED NCT04837586 Self-Weighing for Adolescents Seeking Obesity Treatment RECRUITING NCT07580105 Clinical Study to Assess the Safety and Performance of Kenko Breast AI+ Medical Device as an Aid to Breast Cancer Diagnosis in Adult Women NOT_YET_RECRUITING

Related PubMed Literature

PMID: 28895231 Software-Related Recalls of Health Information Technology and Other Medical Devices: Implications for FDA Regulation of Digital Health. The Milbank quarterly (2017)

Other Devices by Genea Biomedx Pty, Ltd.

K171736Geri Embryo Incubator and Geri Dish K170498Gems Oocyte Retrieval Buffer ORB-20, ORB-50 K162409Gems Vitrification Set, Gems Warming Set K161261Gems Geri Medium, Gems Fertilisation Medium, Gems Cleavage Medium, Gems Blastocyst Medium, Gems VitBase K180304Geri Embryo Incubator and Geri Dish

Related Devices (Code: MQG)

K160504RI Witness Embryology Heated PlateResearch Instruments Limited K151357MIRI TLAt Medical Uab K171736Geri Embryo Incubator and Geri DishGenea Biomedx Pty, Ltd. K160753COOK Vacuum PumpWilliam A. Cook Australia Pty. , Ltd. K173264EmbryoScope+Vitrolife A/S K180304Geri Embryo Incubator and Geri DishGenea Biomedx Pty, Ltd.

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.

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