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FDA 510(k)

QLAB Advanced Quantification Software

K-Number: K200974 · 2020-06-03

ApplicantPhilips Health Care
Decision Date2020-06-03
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

QLAB Advanced Quantification Software is the device name listed in this FDA 510(k) record. The listed applicant is Philips Health Care. It received FDA 510(k) clearance on 2020-06-03 under 510(k) number K200974. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QLAB Advanced Quantification Software?

QLAB Advanced Quantification Software is a medical device that received FDA 510(k) clearance on 2020-06-03. The listed applicant is Philips Health Care. The 510(k) number is K200974.

When did QLAB Advanced Quantification Software receive FDA 510(k) clearance?

QLAB Advanced Quantification Software received FDA 510(k) clearance on 2020-06-03, under 510(k) number K200974.

Who is the listed applicant for QLAB Advanced Quantification Software?

The FDA 510(k) record lists Philips Health Care as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for QLAB Advanced Quantification Software?

The FDA product code for QLAB Advanced Quantification Software is QIH.

Other records listing Philips Health Care 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.

K2013523D Auto LAAK200179Collaboration LiveK191647QLAB Advanced Quantification SoftwareK192226Lumify Diagnostic Ultrasound SystemK190913QLAB Advanced Quantification Software 13K172607Philips EPIQ 5 Diagnostic Ultrasound System, EPIQ 7 Diagnostic Ultrasound System, Affiniti 30 Diagnostic Ultrasound System, Affiniti 50 Diagnostic Ultrasound System, Affiniti 70 Diagnostic Ultrasound System

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Related Devices (Code: QIH)

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.

K253794Prostate CoreLucida Medical, Ltd.K252571mdprostateMediaire GmbHK253902RealGUIDE3DIEMME SRLK253835AffinityHermes Medical Solutions ABK260980cmAngio® V2.0Curemetrix, Inc.K261210Cleerly PlaqueCleerly, 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.

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