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)

Unifi Workspace v1.0.0

K-Number: K190694 · 2019-07-11

ApplicantHologic, Inc.
Decision Date2019-07-11
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Unifi Workspace v1.0.0 is the device name listed in this FDA 510(k) record. The listed applicant is Hologic, Inc.. It received FDA 510(k) clearance on 2019-07-11 under 510(k) number K190694. 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 Unifi Workspace v1.0.0?

Unifi Workspace v1.0.0 is a medical device that received FDA 510(k) clearance on 2019-07-11. The listed applicant is Hologic, Inc.. The 510(k) number is K190694.

When did Unifi Workspace v1.0.0 receive FDA 510(k) clearance?

Unifi Workspace v1.0.0 received FDA 510(k) clearance on 2019-07-11, under 510(k) number K190694.

Who is the listed applicant for Unifi Workspace v1.0.0?

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 Unifi Workspace v1.0.0?

The FDA product code for Unifi Workspace v1.0.0 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.

NCT05199701Prospective Case Collection Study for New Mammography TechnologiesACTIVE_NOT_RECRUITINGNCT06636539Prospective Case Collection Study of Contrast-Enhanced Mammography Imaging Acquired on a New Investigational DeviceACTIVE_NOT_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.

K262792Brevera Biopsy System with CorLumina Imaging Technology (BREVDISP09)K253634CoolSeal Generator® (CSL-200-90)PMA P920048ENZYME IMMUNOASSAY, FETAL FIBRONECTINPMA P010013Device, thermal ablation, endometrialPMA P080003Digital breast tomosynthesisPMA P170025Hepatitis Viral B DNA Detection

View all 56 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.

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑