HipCheck

FDA 510(k) K182359 · Stryker Corp.

Substantially Equivalent

510(k) numberK182359

Submission

Device name
HipCheck
Applicant
Stryker Corp.
San Jose, CA, US
Received
August 30, 2018
Decision date
December 13, 2018
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
K261481Pangea Femur Reconstruction SystemHSB · Traditional 06/29/2026SE
K253640T2 Alpha Femur Retrograde Nailing System; Pangea Femur Reconstruction SystemHSB · Traditional 02/03/2026SE
K253202Hoffmann LRF SystemKTT · Traditional 12/19/2025SE
K251400T2 Alpha Humerus Nailing System; IMN Screws System; T2 Nailing SystemHSB · Traditional 08/20/2025SE
K250163T2 Alpha Femur Retrograde Nailing SystemHSB · Traditional 08/13/2025SE
K242445Pangea Platform; Pangea Femur Plating System; Pangea Humerus Plating System; Pangea…HRS · Traditional 10/06/2024SE
K233919VariAx 2 Distal Radius SystemHRS · Traditional 03/25/2024SE
K233741Hoffmann LRF SystemKTT · Special 12/21/2023SE
K230045HipCheckQIH · Traditional 09/29/2023SE
K2318541788 4K Camera System with Advanced Imaging Modality; L12 LED Light Source with AIMOWN · Traditional 09/20/2023SE

Questions and answers

When was HipCheck cleared by the FDA?

HipCheck (K182359) received a 510(k) decision of Substantially Equivalent on December 13, 2018, 105 days after the submission was received.

What is the product code of K182359?

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