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 the device name listed in this FDA 510(k) record. The listed applicant is Radiopharmaceutical Imaging and Dosimetry, LLC. It received FDA 510(k) clearance on 2023-02-22 under 510(k) 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. The listed applicant is Radiopharmaceutical Imaging and Dosimetry, LLC. The 510(k) number is K212587.

When did 3D-RD-S receive FDA 510(k) clearance?

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

Who is the listed applicant for 3D-RD-S?

The FDA 510(k) record lists Radiopharmaceutical Imaging and Dosimetry, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Devices (Code: IYX)

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.

K230221QDOSE® Multi-purpose Voxel Dosimetry (Personalized Dosimetry in Molecular Radiotherapy)Versant Medical Physics and Radiation Safety K163687OLINDA EXMHermes Medical Solutions AB K160933Discovery NM 750b BopsyGE Healthcare K162052Sentinella 102, Sentinella 102 HorusGeneral Equipment For Medical Imaging (Oncovision-

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.