Hybrid3D
K-Number: K171719 · 2017-11-21
ApplicantHermes Medical Solutions AB
Decision Date2017-11-21
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Hybrid3D is a medical device manufactured by Hermes Medical Solutions AB. It received FDA 510(k) clearance on 2017-11-21 under approval number K171719. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Hybrid3D?
Hybrid3D is a medical device that received FDA 510(k) clearance on 2017-11-21. It is manufactured by Hermes Medical Solutions AB. The 510(k) number is K171719.
When was Hybrid3D approved by the FDA?
Hybrid3D received FDA 510(k) clearance on 2017-11-21, under approval number K171719.
What company makes Hybrid3D?
Hybrid3D is manufactured by Hermes Medical Solutions AB.
What is the FDA product code for Hybrid3D?
The FDA product code for Hybrid3D is KPS.
Other Devices by Hermes Medical Solutions AB
Related Devices (Code: KPS)
K161740D-SPECT Scanner, D-SPECT L ScannerSpectrum Dynamics Medical, Ltd.
K162736Biograph Horizon PET/CT and Biograph mCT PET/CT and Biograph mCT Flow PET/CTSiemens Medical Solutions USA, Inc.
K161674QuantumCamDdd-Diagnostic A/S
K162337Symbia 6.5Siemens Medical Solutions USA, Inc.
K161574Discovery MIGe Medical Systems, LLC
K161631MAMMIGeneral Equipment For Medical Imaging
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.