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FDA 510(k)

QuantX Breast MRI Biopsy Guidance Plugin

K-Number: K191959 · 2019-11-08

ApplicantQlarity Imaging
Decision Date2019-11-08
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

QuantX Breast MRI Biopsy Guidance Plugin is the device name listed in this FDA 510(k) record. The listed applicant is Qlarity Imaging. It received FDA 510(k) clearance on 2019-11-08 under 510(k) number K191959. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the QuantX Breast MRI Biopsy Guidance Plugin?

QuantX Breast MRI Biopsy Guidance Plugin is a medical device that received FDA 510(k) clearance on 2019-11-08. The listed applicant is Qlarity Imaging. The 510(k) number is K191959.

When did QuantX Breast MRI Biopsy Guidance Plugin receive FDA 510(k) clearance?

QuantX Breast MRI Biopsy Guidance Plugin received FDA 510(k) clearance on 2019-11-08, under 510(k) number K191959.

Who is the listed applicant for QuantX Breast MRI Biopsy Guidance Plugin?

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

What is the FDA product code for QuantX Breast MRI Biopsy Guidance Plugin?

The FDA product code for QuantX Breast MRI Biopsy Guidance Plugin is LLZ.

Related Clinical Trials

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.

NCT04808427Pilot Study to Investigate Magnetic Resonance (MR) Image Guided Focal Therapy in Prostate CancerSUSPENDEDNCT06268405Positron Emission Mammography and Liquid Biopsy in Women With High-risk Breast ScreeningsRECRUITINGNCT07120906Augmented Reality Real-Time Guidance for MRI-Guided InterventionsRECRUITING

Related Devices (Code: LLZ)

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.

K262449AdvaViewADVAHEALTH SOLUTIONS, LLCK261916NeuroQuant PETCortechs Labs, Inc.K260936RadioViewAINeurocareai, Inc. (Dba Savelife.Ai)K260588Cleerly LABSCleerly, Inc.K262462TheraSphere 360™ Y-90 Management PlatformBoston Scientific CorporationK262143ImageGrid StreamVueCandelis, Inc.

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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