Infinitt RT PACS
K-Number: K193498 · 2020-02-13
ApplicantInfinitt Healthcare Co., Ltd.
Decision Date2020-02-13
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
Infinitt RT PACS is a medical device manufactured by Infinitt Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2020-02-13 under approval number K193498. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Infinitt RT PACS?
Infinitt RT PACS is a medical device that received FDA 510(k) clearance on 2020-02-13. It is manufactured by Infinitt Healthcare Co., Ltd.. The 510(k) number is K193498.
When was Infinitt RT PACS approved by the FDA?
Infinitt RT PACS received FDA 510(k) clearance on 2020-02-13, under approval number K193498.
What company makes Infinitt RT PACS?
Infinitt RT PACS is manufactured by Infinitt Healthcare Co., Ltd..
What is the FDA product code for Infinitt RT PACS?
The FDA product code for Infinitt RT PACS is LLZ.
Other Devices by Infinitt Healthcare Co., Ltd.
Related Devices (Code: LLZ)
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.