HyperLight Portable X-ray Unit
K-Number: K232068 · 2023-09-01
Decision Date2023-09-01
Product CodeEHD
Advisory CommitteeDE
DecisionSubstantially Equivalent
Device Summary
HyperLight Portable X-ray Unit is a medical device manufactured by Changzhou Sifary Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-09-01 under approval number K232068. The device is classified under product code EHD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HyperLight Portable X-ray Unit?
HyperLight Portable X-ray Unit is a medical device that received FDA 510(k) clearance on 2023-09-01. It is manufactured by Changzhou Sifary Medical Technology Co., Ltd.. The 510(k) number is K232068.
When was HyperLight Portable X-ray Unit approved by the FDA?
HyperLight Portable X-ray Unit received FDA 510(k) clearance on 2023-09-01, under approval number K232068.
What company makes HyperLight Portable X-ray Unit?
HyperLight Portable X-ray Unit is manufactured by Changzhou Sifary Medical Technology Co., Ltd..
What is the FDA product code for HyperLight Portable X-ray Unit?
The FDA product code for HyperLight Portable X-ray Unit is EHD.
Other Devices by Changzhou Sifary Medical Technology Co., Ltd.
Related Devices (Code: EHD)
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.