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FDA 510(k)

QOCA image Smart CXR Image Processing System

K-Number: K221868 · 2023-01-27

ApplicantQuanta Computer, Inc.
Decision Date2023-01-27
Product CodeQFM
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

QOCA image Smart CXR Image Processing System is the device name listed in this FDA 510(k) record. The listed applicant is Quanta Computer, Inc.. It received FDA 510(k) clearance on 2023-01-27 under 510(k) number K221868. 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 QOCA image Smart CXR Image Processing System?

QOCA image Smart CXR Image Processing System is a medical device that received FDA 510(k) clearance on 2023-01-27. The listed applicant is Quanta Computer, Inc.. The 510(k) number is K221868.

When did QOCA image Smart CXR Image Processing System receive FDA 510(k) clearance?

QOCA image Smart CXR Image Processing System received FDA 510(k) clearance on 2023-01-27, under 510(k) number K221868.

Who is the listed applicant for QOCA image Smart CXR Image Processing System?

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

What is the FDA product code for QOCA image Smart CXR Image Processing System?

The FDA product code for QOCA image Smart CXR Image Processing System is QFM.

Other records listing Quanta Computer, 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.

K231855QOCA® image Smart RT Contouring SystemK210179QOCA Portable ECG Monitoring Device

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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