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FDA 510(k)

iRAD

K-Number: K212470 · 2021-10-20

ApplicantClaritas Healthtech Pte, Ltd.
Decision Date2021-10-20
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

iRAD is a medical device manufactured by Claritas Healthtech Pte, Ltd.. It received FDA 510(k) clearance on 2021-10-20 under approval number K212470. 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 iRAD?

iRAD is a medical device that received FDA 510(k) clearance on 2021-10-20. It is manufactured by Claritas Healthtech Pte, Ltd.. The 510(k) number is K212470.

When was iRAD approved by the FDA?

iRAD received FDA 510(k) clearance on 2021-10-20, under approval number K212470.

What company makes iRAD?

iRAD is manufactured by Claritas Healthtech Pte, Ltd..

What is the FDA product code for iRAD?

The FDA product code for iRAD is LLZ.

Other Devices by Claritas Healthtech Pte, Ltd.

K213140Claritas iPET K244016iPETcertum (v1.0)

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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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