HyperLight Portable X-ray Unit
K-Number: K232068 · 2023-09-01
Device Summary
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. The listed applicant is Changzhou Sifary Medical Technology Co., Ltd.. The 510(k) number is K232068.
When did HyperLight Portable X-ray Unit receive FDA 510(k) clearance?
HyperLight Portable X-ray Unit received FDA 510(k) clearance on 2023-09-01, under 510(k) number K232068.
Who is the listed applicant for HyperLight Portable X-ray Unit?
The FDA 510(k) record lists Changzhou Sifary Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
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 records listing Changzhou Sifary Medical Technology Co., Ltd. as applicant
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Related Devices (Code: EHD)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
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.