Focus HD 35 Detector
K-Number: K213646 · 2022-03-29
Device Summary
Frequently Asked Questions
What is the Focus HD 35 Detector?
Focus HD 35 Detector is a medical device that received FDA 510(k) clearance on 2022-03-29. The listed applicant is Iray Technology Taicang , Ltd.. The 510(k) number is K213646.
When did Focus HD 35 Detector receive FDA 510(k) clearance?
Focus HD 35 Detector received FDA 510(k) clearance on 2022-03-29, under 510(k) number K213646.
Who is the listed applicant for Focus HD 35 Detector?
The FDA 510(k) record lists Iray Technology Taicang , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Focus HD 35 Detector?
The FDA product code for Focus HD 35 Detector is MQB.
Other records listing Iray Technology Taicang , 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: MQB)
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.