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FDA 510(k)

Kinepict Medical Imaging Tool 4.0

K-Number: K202056 · 2021-09-10

Decision Date2021-09-10
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Kinepict Medical Imaging Tool 4.0 is the device name listed in this FDA 510(k) record. The listed applicant is Kinepict Health, Ltd.. It received FDA 510(k) clearance on 2021-09-10 under 510(k) number K202056. 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 Kinepict Medical Imaging Tool 4.0?

Kinepict Medical Imaging Tool 4.0 is a medical device that received FDA 510(k) clearance on 2021-09-10. The listed applicant is Kinepict Health, Ltd.. The 510(k) number is K202056.

When did Kinepict Medical Imaging Tool 4.0 receive FDA 510(k) clearance?

Kinepict Medical Imaging Tool 4.0 received FDA 510(k) clearance on 2021-09-10, under 510(k) number K202056.

Who is the listed applicant for Kinepict Medical Imaging Tool 4.0?

The FDA 510(k) record lists Kinepict Health, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Kinepict Medical Imaging Tool 4.0?

The FDA product code for Kinepict Medical Imaging Tool 4.0 is LLZ.

Other records listing Kinepict Health, 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: LLZ)

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

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