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)

SECURVIEW DX SOFTCOPY WORKSTATION

K-Number: K041555 · 2004-08-09

ApplicantHologic, Inc.
Decision Date2004-08-09
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

SECURVIEW DX SOFTCOPY WORKSTATION is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2004-08-09 under 510(k) number K041555. 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 SECURVIEW DX SOFTCOPY WORKSTATION?

SECURVIEW DX SOFTCOPY WORKSTATION is a medical device that received FDA 510(k) clearance on 2004-08-09. The listed applicant is Hologic, Inc.. The 510(k) number is K041555.

When did SECURVIEW DX SOFTCOPY WORKSTATION receive FDA 510(k) clearance?

SECURVIEW DX SOFTCOPY WORKSTATION received FDA 510(k) clearance on 2004-08-09, under 510(k) number K041555.

Who is the listed applicant for SECURVIEW DX SOFTCOPY WORKSTATION?

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 SECURVIEW DX SOFTCOPY WORKSTATION?

The FDA product code for SECURVIEW DX SOFTCOPY WORKSTATION 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.

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: 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.

K261874Syneris PACS v.1.0.1.0SynerisK262442HipStudio AnalysisReplasia BVK261855Elucid PlaqueIQElucid Bioimaging, Inc.K254214OOOPDSTaiwan Main Orthopaedic Biotechnology Co., Ltd.K261861SPINEsim v1.0Mdsim S.A.K2620603D-RD-SRadiopharmaceutical Imaging & Dosimetry, LLC

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.

↑