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FDA 510(k)

Q-Rad System

K-Number: K193574 · 2020-01-22

Decision Date2020-01-22
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Q-Rad System is the device name listed in this FDA 510(k) record. The listed applicant is Carestream Health, Inc.. It received FDA 510(k) clearance on 2020-01-22 under 510(k) number K193574. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Q-Rad System?

Q-Rad System is a medical device that received FDA 510(k) clearance on 2020-01-22. The listed applicant is Carestream Health, Inc.. The 510(k) number is K193574.

When did Q-Rad System receive FDA 510(k) clearance?

Q-Rad System received FDA 510(k) clearance on 2020-01-22, under 510(k) number K193574.

Who is the listed applicant for Q-Rad System?

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

What is the FDA product code for Q-Rad System?

The FDA product code for Q-Rad System is KPR.

Other records listing Carestream Health, Inc. 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.

View all 28 devices →

Related Devices (Code: KPR)

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.