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)

Enterprise Imaging XERO Viewer 8.1

K-Number: K170434 · 2017-07-03

ApplicantAgfa Healthcare N.V.
Decision Date2017-07-03
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Enterprise Imaging XERO Viewer 8.1 is the device name listed in this FDA 510(k) record. The listed applicant is Agfa Healthcare N.V.. It received FDA 510(k) clearance on 2017-07-03 under 510(k) number K170434. 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 Enterprise Imaging XERO Viewer 8.1?

Enterprise Imaging XERO Viewer 8.1 is a medical device that received FDA 510(k) clearance on 2017-07-03. The listed applicant is Agfa Healthcare N.V.. The 510(k) number is K170434.

When did Enterprise Imaging XERO Viewer 8.1 receive FDA 510(k) clearance?

Enterprise Imaging XERO Viewer 8.1 received FDA 510(k) clearance on 2017-07-03, under 510(k) number K170434.

Who is the listed applicant for Enterprise Imaging XERO Viewer 8.1?

The FDA 510(k) record lists Agfa Healthcare N.V. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Enterprise Imaging XERO Viewer 8.1?

The FDA product code for Enterprise Imaging XERO Viewer 8.1 is LLZ.

Other records listing Agfa Healthcare N.V. 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.

K252199AGFA HealthCare Enterprise ImagingK180589DR 800 with MUSICA DynamicK172784DX-D Imaging PackageK161368DX-D Imaging Package (DR 10s), DX-D Imaging Package (DR 14s), DX-D Imaging Package (DR 14s)K161061IMPAX Volume Viewing 4.0

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.

↑