Discovery NM 750b Bopsy
K-Number: K160933 · 2016-11-18
ApplicantGE Healthcare
Decision Date2016-11-18
Product CodeIYX
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Discovery NM 750b Bopsy is a medical device manufactured by GE Healthcare. It received FDA 510(k) clearance on 2016-11-18 under approval number K160933. The device is classified under product code IYX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Discovery NM 750b Bopsy?
Discovery NM 750b Bopsy is a medical device that received FDA 510(k) clearance on 2016-11-18. It is manufactured by GE Healthcare. The 510(k) number is K160933.
When was Discovery NM 750b Bopsy approved by the FDA?
Discovery NM 750b Bopsy received FDA 510(k) clearance on 2016-11-18, under approval number K160933.
What company makes Discovery NM 750b Bopsy?
Discovery NM 750b Bopsy is manufactured by GE Healthcare.
What is the FDA product code for Discovery NM 750b Bopsy?
The FDA product code for Discovery NM 750b Bopsy is IYX.
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: IYX)
K162052Sentinella 102, Sentinella 102 HorusGeneral Equipment For Medical Imaging (Oncovision-
K163687OLINDA EXMHermes Medical Solutions AB
K230221QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)Versant Medical Physics and Radiation Safety
K2125873D-RD-SRadiopharmaceutical Imaging and Dosimetry, LLC
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.