uDR 592h, uDR 596i
K-Number: K192293 · 2019-09-12
Device Summary
Frequently Asked Questions
What is the uDR 592h, uDR 596i?
uDR 592h, uDR 596i is a medical device that received FDA 510(k) clearance on 2019-09-12. The listed applicant is Shanghai United Imaging Healthcare Co., Ltd.. The 510(k) number is K192293.
When did uDR 592h, uDR 596i receive FDA 510(k) clearance?
uDR 592h, uDR 596i received FDA 510(k) clearance on 2019-09-12, under 510(k) number K192293.
Who is the listed applicant for uDR 592h, uDR 596i?
The FDA 510(k) record lists Shanghai United Imaging Healthcare Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for uDR 592h, uDR 596i?
The FDA product code for uDR 592h, uDR 596i is KPR.
Other records listing Shanghai United Imaging Healthcare 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: KPR)
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.