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FDA 510(k)

3D-RD-S

K-Number: K212587 · 2023-02-22

ApplicantRadiopharmaceutical Imaging and Dosimetry, LLC
Decision Date2023-02-22
Product CodeIYX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

3D-RD-S is a medical device manufactured by Radiopharmaceutical Imaging and Dosimetry, LLC. It received FDA 510(k) clearance on 2023-02-22 under approval number K212587. The device is classified under product code IYX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 3D-RD-S?

3D-RD-S is a medical device that received FDA 510(k) clearance on 2023-02-22. It is manufactured by Radiopharmaceutical Imaging and Dosimetry, LLC. The 510(k) number is K212587.

When was 3D-RD-S approved by the FDA?

3D-RD-S received FDA 510(k) clearance on 2023-02-22, under approval number K212587.

What company makes 3D-RD-S?

3D-RD-S is manufactured by Radiopharmaceutical Imaging and Dosimetry, LLC.

What is the FDA product code for 3D-RD-S?

The FDA product code for 3D-RD-S is IYX.

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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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