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)

IVA (MXA II SOFTWARE OPTION)

K-Number: K060111 · 2006-04-24

ApplicantHologic, Inc.
Decision Date2006-04-24
Product CodeKGI
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

IVA (MXA II SOFTWARE OPTION) is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2006-04-24 under 510(k) number K060111. The device is classified under product code KGI. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IVA (MXA II SOFTWARE OPTION)?

IVA (MXA II SOFTWARE OPTION) is a medical device that received FDA 510(k) clearance on 2006-04-24. The listed applicant is Hologic, Inc.. The 510(k) number is K060111.

When did IVA (MXA II SOFTWARE OPTION) receive FDA 510(k) clearance?

IVA (MXA II SOFTWARE OPTION) received FDA 510(k) clearance on 2006-04-24, under 510(k) number K060111.

Who is the listed applicant for IVA (MXA II SOFTWARE OPTION)?

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

What is the FDA product code for IVA (MXA II SOFTWARE OPTION)?

The FDA product code for IVA (MXA II SOFTWARE OPTION) is KGI.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Hologic, 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.

K254090I-View®K262792Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)K253634CoolSeal Generator® (CSL-200-90)K251993Panther Fusion GI Expanded Bacterial AssayK243341Genius AI Detection 2.0K243396Aptima SARS-CoV-2 Assay

View all 109 devices →

Related Devices (Code: KGI)

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.

K254072BoneVueCurvebeam AI / Curvebeam, LLCK252718Lunar AstraGE Medical Systems Ultrasound & Primary Care Diagnostics, LLCK2510223D-SHAPER3D-Shaper Medical S.LK242295BunkerHill BMDBunkerHill HealthK243218TBS iNsight (V4)Medimaps Group SAK220402VirtuOstO.N. Diagnostics

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.

↑