Optima XR646 HD
K-Number: K173612 · 2017-12-11
Device Summary
Frequently Asked Questions
What is the Optima XR646 HD?
Optima XR646 HD is a medical device that received FDA 510(k) clearance on 2017-12-11. The listed applicant is Ge Hualun Medical Systems Co. , Ltd.. The 510(k) number is K173612.
When did Optima XR646 HD receive FDA 510(k) clearance?
Optima XR646 HD received FDA 510(k) clearance on 2017-12-11, under 510(k) number K173612.
Who is the listed applicant for Optima XR646 HD?
The FDA 510(k) record lists Ge Hualun Medical Systems Co. , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Optima XR646 HD?
The FDA product code for Optima XR646 HD is KPR.
Other records listing Ge Hualun Medical Systems 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.