Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3019878658

FEI Number

3019878658

Entity Name

INSIGHT MEDICAL SYSTEMS, INC

City/State/Country

Austin, TX, US

Establishment Address

9801 Metric Boulevard, Austin, TX 78758, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Kico Knee Innovation Company (Owner Number: 10054916)

Owner / Operator Contact Address

Unit 1, 25 Frenchs Forest Rd E, Frenchs Forest, AU-NSW 2086, AU

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K243950

PMA Number

N/A

All Registered Proprietary Names

ARVIS® Shoulder ARVIS Surgical Navigation System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
SBF	Orthopedic Augmented Reality	Neurology	Class 2	882.4560	2025-08-03
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2025-08-03
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2025-08-03

Official Correspondent

Danyon Munro

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Kico Knee Innovation Company

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
3013552417	KICO KNEE INNOVATION COMPANY	Frenchs Forest New South Wales, AU

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K242270	Orthofix Srl	OrthoNext Platform System	2024-12-19
K261713	FUJIFILM Healthcare Americas Corporation	Synapse PACS (7.6.0)	2026-06-18
K243647	FUJIFILM Healthcare Americas Corporation	Synapse PACS (7.5)	2025-06-30
K080013	Agfa Healthcare Corporation	REGISTRATION AND FUSION	2008-01-17
K042221	Barco NV Barcoview	CORONIS 5MP MEDICAL FLAT PANEL DISPLAY SYSTEM	2004-12-30

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.
Z-0030-2026	CHANGE HEALTHCARE CANADA COMPANY	2	Change Healthcare Radiology Solutions software version 14.2.2
Z-0032-2012	Philips Healthcare Inc.	2	MDC PACS - release R2.3 SP1 . Phillips Healthcare Andover, Massachusetts A software application that is used for receiving, managing, archiving, distributing and recording medical images onto portable digital media (including but not limited to Compact Disk and DVD).
Z-0033-2007	AGFA Corp.	2	IMPAX 5.2 Systems with CAD Capability (Computer Assisted Diagnosis)

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3010031846	proNet, A Division Desco Industries Inc.	Anaheim, CA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3019878658. Last updated year: 2026. Please use registration number 3019878658 when referencing this establishment in official correspondence.