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FDA 510(k)

Medical Radiation Dosimetry System microSTARii

K-Number: K192196 · 2019-12-27

ApplicantLandauer
Decision Date2019-12-27
Product CodeIYE
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Medical Radiation Dosimetry System microSTARii is the device name listed in this FDA 510(k) record. The listed applicant is Landauer. It received FDA 510(k) clearance on 2019-12-27 under 510(k) number K192196. The device is classified under product code IYE. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Medical Radiation Dosimetry System microSTARii?

Medical Radiation Dosimetry System microSTARii is a medical device that received FDA 510(k) clearance on 2019-12-27. The listed applicant is Landauer. The 510(k) number is K192196.

When did Medical Radiation Dosimetry System microSTARii receive FDA 510(k) clearance?

Medical Radiation Dosimetry System microSTARii received FDA 510(k) clearance on 2019-12-27, under 510(k) number K192196.

Who is the listed applicant for Medical Radiation Dosimetry System microSTARii?

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

What is the FDA product code for Medical Radiation Dosimetry System microSTARii?

The FDA product code for Medical Radiation Dosimetry System microSTARii is IYE.

Related Devices (Code: IYE)

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.

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Official Source

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