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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 a medical device manufactured by Quanta Computer, Inc.. It received FDA 510(k) clearance on 2023-01-27 under approval 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. It is manufactured by Quanta Computer, Inc.. The 510(k) number is K221868.

When was QOCA image Smart CXR Image Processing System approved by the FDA?

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

What company makes QOCA image Smart CXR Image Processing System?

QOCA image Smart CXR Image Processing System is manufactured by Quanta Computer, Inc..

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.

Related Clinical Trials

NCT04981223 Predicting Location and Extent of Prostate Cancer Using Micro-Ultrasound Imaging COMPLETED NCT07603258 Access-H20: Sensor-driven Smart Faucet Related Study COMPLETED NCT04488224 Nano-X Image Guidance: CBCT With Gravity-induced Motion WITHDRAWN NCT06868979 Optical Imaging in X-linked Disorders. RECRUITING NCT07042620 A Study to Test a New Fluid to Improve the Quality of Images Obtained by Using Sound Waves (Ultrasound) During Surgery ACTIVE_NOT_RECRUITING NCT03031587 Validation of Thermometric Cardiac Imaging by MRI COMPLETED

Related PubMed Literature

PMID: 42056377 Signal detection of adverse events in medical devices using natural language processing: a case study in pelvic mesh. Scientific reports (2026) PMID: 39941212 Artificial Intelligence-Empowered Radiology-Current Status and Critical Review. Diagnostics (Basel, Switzerland) (2025)

Other Devices by Quanta Computer, Inc.

K210179QOCA Portable ECG Monitoring Device K231855QOCA® image Smart RT Contouring System

Related Devices (Code: QFM)

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Official Source

View on FDA Database →

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