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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 the device name listed in this FDA 510(k) record. The listed applicant is Radlogics, Inc.. It received FDA 510(k) clearance on 2020-04-08 under 510(k) 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. The listed applicant is Radlogics, Inc.. The 510(k) number is K193300.

When did AIMI-Triage CXR PTX receive FDA 510(k) clearance?

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

Who is the listed applicant for AIMI-Triage CXR PTX?

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

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

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

Related Devices (Code: QFM)

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.

K253751CXRDetectAINeurocareai, Inc. (Dba Savelife.Ai)K252954MammoSightAINeurocareai, Inc. (Dba Savelife.Ai)K252482CogNet AI-MT+Medcognetics, Inc.K250831Annalise EnterpriseAnnalise-AiK243808Rayvolve PTX-PEAZmedK243548BriefCase-TriageAidoc Medical , Ltd.

Official Source

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

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