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FDA 510(k)

AIMI-Triage CXR PTX

K-Number: K193300 · 2020-04-08

ApplicantRadlogics, Inc.
Decision Date2020-04-08
Product CodeQFM
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

AIMI-Triage CXR PTX is a medical device manufactured by Radlogics, Inc.. It received FDA 510(k) clearance on 2020-04-08 under approval number K193300. The device is classified under product code QFM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AIMI-Triage CXR PTX?

AIMI-Triage CXR PTX is a medical device that received FDA 510(k) clearance on 2020-04-08. It is manufactured by Radlogics, Inc.. The 510(k) number is K193300.

When was AIMI-Triage CXR PTX approved by the FDA?

AIMI-Triage CXR PTX received FDA 510(k) clearance on 2020-04-08, under approval number K193300.

What company makes AIMI-Triage CXR PTX?

AIMI-Triage CXR PTX is manufactured by Radlogics, Inc..

What is the FDA product code for AIMI-Triage CXR PTX?

The FDA product code for AIMI-Triage CXR PTX is QFM.

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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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