HYPER Focus
K-Number: K210418 · 2021-04-09
Decision Date2021-04-09
Product CodeKPS
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
HYPER Focus is a medical device manufactured by Shanghai United Imaging Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2021-04-09 under approval number K210418. 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 HYPER Focus?
HYPER Focus is a medical device that received FDA 510(k) clearance on 2021-04-09. It is manufactured by Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K210418.
When was HYPER Focus approved by the FDA?
HYPER Focus received FDA 510(k) clearance on 2021-04-09, under approval number K210418.
What company makes HYPER Focus?
HYPER Focus is manufactured by Shanghai United Imaging Healthcare Co., Ltd..
What is the FDA product code for HYPER Focus?
The FDA product code for HYPER Focus is KPS.
Other Devices by Shanghai United Imaging Healthcare Co., Ltd.
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.