Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

QOCA® image Smart RT Contouring System

K-Number: K231855 · 2024-02-13

ApplicantQuanta Computer, Inc.
Decision Date2024-02-13
Product CodeQKB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

QOCA® image Smart RT Contouring 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 2024-02-13 under 510(k) number K231855. The device is classified under product code QKB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QOCA® image Smart RT Contouring System?

QOCA® image Smart RT Contouring System is a medical device that received FDA 510(k) clearance on 2024-02-13. The listed applicant is Quanta Computer, Inc.. The 510(k) number is K231855.

When did QOCA® image Smart RT Contouring System receive FDA 510(k) clearance?

QOCA® image Smart RT Contouring System received FDA 510(k) clearance on 2024-02-13, under 510(k) number K231855.

Who is the listed applicant for QOCA® image Smart RT Contouring 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 RT Contouring System?

The FDA product code for QOCA® image Smart RT Contouring System is QKB.

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.

K221868QOCA image Smart CXR Image Processing SystemK210179QOCA Portable ECG Monitoring Device

Related Devices (Code: QKB)

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.

K262452AutoContour (RADAC V6)Radformation, Inc.K261306AI Contouring (VA10A)Varian Medical SystemsK260528OncoStudioOncosoft. Inc.,K252548AI-Rad Companion Organs RTSiemens Healthcare GmbHK252190DeepBT Detector-PlusAitewan Biomedical Technology, Inc.K253270Contour ProtégéAI+Mim Software, Inc.

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.

↑