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FDA 510(k)

Infinitt PACS 7.0

K-Number: K172803 · 2017-10-27

ApplicantInfinitt Healthcare Co., Ltd.
Decision Date2017-10-27
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Infinitt PACS 7.0 is a medical device manufactured by Infinitt Healthcare Co., Ltd.. It received FDA 510(k) clearance on 2017-10-27 under approval number K172803. 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 PACS 7.0?

Infinitt PACS 7.0 is a medical device that received FDA 510(k) clearance on 2017-10-27. It is manufactured by Infinitt Healthcare Co., Ltd.. The 510(k) number is K172803.

When was Infinitt PACS 7.0 approved by the FDA?

Infinitt PACS 7.0 received FDA 510(k) clearance on 2017-10-27, under approval number K172803.

What company makes Infinitt PACS 7.0?

Infinitt PACS 7.0 is manufactured by Infinitt Healthcare Co., Ltd..

What is the FDA product code for Infinitt PACS 7.0?

The FDA product code for Infinitt PACS 7.0 is LLZ.

Other Devices by Infinitt Healthcare Co., Ltd.

K193369Xelis Dental 2.0 K193498Infinitt RT PACS K243449INFINITT DPS

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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.

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