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FDA 510(k)

3Dicom MD

K-Number: K222470 · 2022-10-25

ApplicantSingular Health Pty, Ltd.
Decision Date2022-10-25
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

3Dicom MD is a medical device manufactured by Singular Health Pty, Ltd.. It received FDA 510(k) clearance on 2022-10-25 under approval number K222470. 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 3Dicom MD?

3Dicom MD is a medical device that received FDA 510(k) clearance on 2022-10-25. It is manufactured by Singular Health Pty, Ltd.. The 510(k) number is K222470.

When was 3Dicom MD approved by the FDA?

3Dicom MD received FDA 510(k) clearance on 2022-10-25, under approval number K222470.

What company makes 3Dicom MD?

3Dicom MD is manufactured by Singular Health Pty, Ltd..

What is the FDA product code for 3Dicom MD?

The FDA product code for 3Dicom MD is LLZ.

Other Devices by Singular Health Pty, Ltd.

K2537843DICOM MD Cloud

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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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