Mckesson Horizon Cardiology

FDA 510(k) K112720 · Mckesson Israel , Ltd.

Substantially Equivalent

510(k) numberK112720

Submission

Device name
Mckesson Horizon Cardiology
Applicant
Mckesson Israel , Ltd.
Tel Aviv, IL
Received
September 19, 2011
Decision date
January 30, 2012
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
LLZ – System, Image Processing, Radiological
Device class
Class II (moderate risk)
Regulation
21 CFR 892.2050
Specialty
Radiology

Other 510(k)s with product code LLZ

510(k)DeviceApplicantDecision
K2620603D-RD-SLLZ · Traditional Radiopharmaceutical Imaging & Dosimetry, LLC09/04/2026SE
K261500KBA3D (v2.4.0)LLZ · Traditional S.M.A.I.O08/17/2026SE
K262449AdvaViewLLZ · Special Advahealth Solutions, LLC08/14/2026SE
K261916NeuroQuant PETLLZ · Traditional Cortechs Labs, Inc.08/12/2026SE
K260936RadioViewAILLZ · Traditional Neurocareai, Inc. (Dba Savelife.Ai)07/31/2026SE
K260588Cleerly LABSLLZ · Traditional Cleerly, Inc.07/29/2026SE
K262462TheraSphere 360™ Y-90 Management PlatformLLZ · Special Boston Scientific Corporation07/24/2026SE
K262143ImageGrid StreamVueLLZ · Traditional Candelis, Inc.07/23/2026SE
K260500ResolutionMDLLZ · Traditional ResolutionMD, Inc.07/21/2026SE
K262120Avara ViewerLLZ · Traditional Avara Software07/10/2026SE

More from Avara Software

510(k)DeviceDecision
K151850McKesson CardiologyLLZ · Traditional 08/11/2015SE
K133534Mckesson Cardiology ECG MobileDQK · Traditional 04/18/2014SE
K131497Mckesson Cardiology HemoMWI · Traditional 12/05/2013SE
K113515Horizon Cardiology ECG ManagementDQK · Traditional 03/16/2012SE

Questions and answers

When was Mckesson Horizon Cardiology cleared by the FDA?

Mckesson Horizon Cardiology (K112720) received a 510(k) decision of Substantially Equivalent on January 30, 2012, 133 days after the submission was received.

What is the product code of K112720?

The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.